Author Archives: Sentry

Sentry team to participate in the 2019 Susan G. Komen Race for the Cure ®

This Saturday, April 27^th, 2019 several Sentry BioPharma Services team members will be proudly participating in the 2019 Komen Central Indiana Race for the Cure ®.

Over the years this event has raised more than $2 billion dollars to help fund research, education, screening and treatment. This event is unique in that 100% of the net proceeds are invested in the Komen mission. 25% of all funds go towards research to learn about the biology of breast cancer, advance new screening technologies, develop better treatment protocols and combat metastatic disease. The remaining 75% is invested in locally through a community grants program. Last year $697,047 was invested in 9 local breast health programs and provide 40,000 services within a 41-county service area in Indiana.

Our team realizes that fundraising is critical to helping breast cancer patients living right here in central Indiana. These sobering statistics from the Central Indiana Susan G. Komen website help to bring that need even more into focus.

1 in 8 women in the U.S. will be diagnosed with breast cancer in her lifetime.
Every 19 seconds, somewhere in the world, a case of breast cancer is diagnosed.
Every 60 seconds, somewhere in the world, someone dies from breast cancer.
Every 13 minutes, one woman in the U.S will lose her life to breast cancer.
At the current rate, 13 million breast cancer deaths will occur around the world in the next 25 years.

Sentry is determined to take action and this event is our chance to support the Komen organization in its efforts to end breast cancer forever.

For more info on how you can help please visit the Susan G. Komen® website.

Biologics Contribute to Growth in Pharma Products Cold-Chain Market

In its September issue, Pharmaceutical Commerce details the previous and expected contributions of biologic products to its forecast of cold-chain market growth predicting sales of cold-chain drugs and biologics will outpace overall industry growth through 2022.

It is reported that “as of 2018, global sales of biotech drugs and biologic products exceed $300 billion in value, and the special logistics for maintaining the quality of such temperature-sensitive products as they are shipped from manufacturers to hospitals, clinics, pharmacies and patients around the world account for more than 17% of all biopharma logistics spending”.

The updated forecast for cold-chain logistics spending in 2018 is that “it will be more than $15 billion worldwide, in an $82 billion overall pharma logistics market, of which $10.6 billion will be transportation and $4.4 billion will be specialized tertiary packaging and instrumentation such as insulated boxes, blankets, phase-change materials, shipping containers and various temperature sensors and recorders. By 2022, cold-chain biopharma logistics spending will expand to more than $18 billion.”

To read the full article visit the following link:

https://pharmaceuticalcommerce.com/cold-chain-focus/biopharma-cold-chain-market-forecast/

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated GMP storage, labeling, kitting and temperature-sensitive drug distribution services. For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.

FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products

In a recent news release the FDA described research it has conducted regarding detection of protein carbonylation, an oxidative reaction that may occur in therapeutic protein drug products during manufacture, storage, use, and transport potentially causing structural alterations and threatening stability, quality, and clinical efficacy of such products. FDA scientists have refined an antibody-binding assay with high sensitivity to detect protein carbonylation allowing many samples to be studied in a short period of time under a variety of conditions. The assay is being used to study the tendencies of various protein products to undergo oxidative carbonylation and whether containers and chemicals that contact proteins may start or speed up these reactions. The goal is to develop methods such as addition of stabilizing agents to counteract protein carbonylation in order to maintain stability, purity, and potency of therapeutic protein products and to avoid any harmful adverse reactions such as unwanted immune responses.

See https://www.fda.gov/Drugs/NewsEvents/ucm571068.htm

Full FDA Story:

The potential for biotechnology to transform medicine remains immense, with several therapeutic protein products already having come into widespread clinical use and hundreds of proteins under clinical investigation. For the FDA, the regulatory oversight of therapeutic protein development poses a great challenge, not only because of the increasing number of products, but also because proteins, by their very nature, are highly variable, and compared to small-molecule drugs, more likely to undergo chemical reactions over time. Chemical reactions that occur in these proteins (for example, during storage in vials before administration to patients) can have a significant impact on protein function. For FDA scientists in the CDER Office of Biotechnology Products (OBP), these reactions are of great interest because they can directly impact the quality, safety, and efficacy of protein products.

For decades—before the biotechnological revolution and the rise of therapeutic proteins—FDA drug reviewers focused primarily on small-molecule drugs. Aspirin, for example, contains only nine carbon atoms, whereas the modern protein product bevacizumab contains well over 6,000 carbon atoms. In general, proteins also contain sulfur atoms (bevacizumab has 44!), and biochemists have long known that sulfur-containing molecules are prone to undergo reactions related to the presence of unstable oxygen and other atoms in our environment. (Proteins are not the only molecules that undergo such oxidative reactions. The rusting of iron tools and statues, where iron atoms interact with oxygen atoms in the air and water, is also oxidative.) In some instances, oxidized proteins can be damaged in various ways, which could in turn trigger an unwanted immune response in patients. This feature is a unique concern with therapeutic proteins.

Recently, biochemists have begun to investigate the exact locations of oxidative reactions within large intact protein molecules. Laboratory researchers in OBP, for example, have published important new information (see References) concerning protein carbonylation, which entails the addition of a single atom of oxygen, originating from the environment, to discrete carbon atoms (rather than sulfur atoms) within protein molecules. Although protein carbonylation has been recognized within the context of disease and age-related conditions, its occurrence during the manufacture, storage, use, and transport of therapeutic proteins is a relatively new area of study. For pharmaceutical quality scientists, key issues include: understanding the different tendencies of various protein products to undergo oxidative carbonylation; identifying the role that containers and chemicals that contact proteins may have in these reactions; and discovering reliable methods for specifically and consistently detecting and controlling carbonylation.

To detect protein carbonylation, the OBP team has refined an antibody-binding assay that takes advantage of the reactivity of the “carbonyl group,” which is the name given to the carbon- and oxygen-atom grouping that occurs upon protein carbonylation. Carbonyl groups that form in proteins can make the entire protein molecule less stable and lead to damage after degradation or aggregation. By exposing the carbonyl groups that are formed in proteins to a laboratory reagent known as DNPH, the OBP team found that different proteins undergo carbonylation at different levels and at specific sites. The rate and site of carbonylation can depend on temperature, time, and other variables, such as the presence of small amounts of metals that accelerate protein oxidation reactions. The laboratory also investigated the tendency for certain additives in drug formulations to start or speed up these reactions. The methods developed by the team allow many samples, under a variety of conditions, to be studied in a short period of time. Moreover, the method is sensitive enough to detect as little as a single carbonylation modification within a large protein molecule.

The findings of the OBP team may help protein drug developers produce therapeutic proteins under optimized manufacturing conditions, potentially with structural alterations or by adding stabilizing additives that could prevent harmful carbonylation reactions. More stable protein drugs could offer a longer shelf life, reduced risk of quality problems, and more predictable clinical performance. Understanding reactions such as protein carbonylation may result in improved versions of current drugs or new drugs with superior stability, purity, and potency. Above all, the goal is to have safe and effective high-quality protein products available for patients.

Sentry representatives attend DCAT week

Sentry BioPharma Services is pleased to announce delegates from Sentry’s Business Development team will be in New York City attending the Drug, Chemical & Associated Technologies Association (DCAT) Week March 19^th -22^nd. The four-day conference brings together key sourcing, procurement and business development stakeholders within the industry’s top life science organizations. The Sentry team’s focus will be to connect with current clients and prospective pharmaceutical development and manufacturing companies requiring first-in-class temperature-sensitive product management and global distribution support.

President Tim Mitchell and Business Development Manager Alex Mitchell are looking forward to discussing Sentry’s GMP pharmaceutical storage expertise and expanded service offerings coming throughout 2018 and 2019. They along with representatives from our marketing team will be sharing information regarding Sentry’s services to include:

Six validated storage environments
- +15°C to +30°C
- +2°C to +8°C
- -15°C to -25°C
- -33°C to -43°C
- -40°C to -60°C
- -70°C to -90°C
- Custom Temperature Solutions from 0°C to -90°C
Controlled Substance Storage and Security
Secondary Labeling and Packaging
Foreign Trade Zone Import/Export Support
Government, Seasonal/Pandemic, Vaccine and Bio-defense Stockpile and Distribution Support

API Sampling and Dispensing

Commercial Fulfillment

Schedule a strategic meeting with the Business Development team to learn how Sentry can optimize GMP solutions for your clinical and commercial project needs.

EMA Announces Brexit Business Continuity Plan

In a press release issued on August 1, 2017, The European Medicines Agency (EMA) announced that it “has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom’s (UK’s) withdrawal from the European Union (EU) and the Agency’s relocation”. It was indicated the plan is intended to “preserve Agency’s ability to protect public and animal health”.

The plan outlines 3 categories of EMA activities and prioritizes them “according to their impact on public health and the Agency’s ability to function”.

Category 1, the highest priority activities, includes those related to the assessment and safety monitoring of medicines such as actions taken to protect patient safety and inspections across the EU, or activities vital to maintaining the infrastructure and functionality of the EU regulatory system for medicines such as security of critical IT applications. EMA stated, “It is absolutely crucial to uphold these activities as any disruption would almost immediately have a detrimental effect on the health and well being of citizens in Europe and would also jeopardize production and distribution of medicines in the EU”.

Category 2 activities include the proactive publication of clinical data, various initiatives aimed at promoting availability of medicines, and projects such as EMA’s contribution to the fight against antimicrobial resistance or the Agency’s interactions with Health Technology Assessment (HTA) bodies. EMA indicated, “These activities will be maintained for as long as possible, workload and staffing situation permitting, in order to maintain the development of new medicines”.

However, in order to reallocate personnel for preparations for the UK’s withdrawal from the EU and EMA’s relocation, EMA has already begun to suspend activities in what it terms category 3 including:

“the development of the European Medicines Web Portal, a new publicly-available online information intended to be a single-source for information on all medicines marketed in the EU;

EMA’s contribution to the e-submission project that will allow applicants to electronically submit documents linked to authorization requests for human and veterinary medicines in a secure and efficient way;

the development of a transparency roadmap for EMA that lays out future transparency measures of the Agency; and

participation in the benchmarking of medicines regulatory authorities in the EU as of 2018.”

EMA said it was also reducing the number of audits, some corporate governance and support activities, EMA meetings and workshops, and participation of EMA staff in external meetings or conferences.

EMA said it will consider “how long these activities can be put on hold before they start to seriously undermine the quality of the Agency’s work and its planning, and the expectations of stakeholders”. However, the press release concludes rather ominously stating, “Further iterations of the business continuity plan will also take into account various scenarios for staff losses and how these may affect the delivery of category 1 and 2 activities. Unexpected higher, faster or more permanent loss of staff as a consequence of the Agency’s relocation may lead to a situation in which EMA’s operations can no longer be maintained.”

Source: https://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/07/news_detail_002789.jsp&mid=WC0b01ac058004d5c1

EU Countries Contend to Be New Host Country of the European Medicines Agency

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting. Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients.

The European Medicines Agency, (EMA), oversees medicine regulation within the EU and evaluates applications for medicines to receive marketing authorization across the bloc. It has been based in London since it was founded in 1995.

However, as Brexit is completed the regulatory body will move from its current headquarters in London and as many as 20 EU countries may bid to host the headquarters of the EMA and its staff of almost 1000.

Portugal is the latest to join the competition and other contenders include the Netherlands, Ireland, Sweden, Austria, Denmark and Spain. Potential interest has also been expressed by Belgium, France, Germany, Luxembourg, Finland, Cyprus, Malta, Greece, Portugal, Slovenia, Slovakia, Poland and Hungary. Only the Czech Republic and Estonia have said they would not be vying for the EMA headquarters.

No precise timetable for the transfer has been set, and the EMA itself will have no direct say in the decision. Rather, representatives of the EU Member States will vote to determine the outcome.

Hosting the headquarters should be financially attractive. In addition to the large permanent staff, regulators from member countries are constantly in attendance at the headquarters for meetings and work. It could also be expected that established international big pharma companies as well as emerging European pharmaceutical businesses might locate offices or headquarters in the EMA host city.

However, a number of potential problems loom as the relocation is considered. Pharmaceutical companies fear there could be drug approval delays when the headquarters makes its move. Reportedly a large number of senior staff have left EMA since the Brexit vote and EMA is also likely to suffer a further loss because of the significant amount of review and approval work done by the UK Medicines & Healthcare Products Regulatory Agency (MHRA). And, the MHRA will face a challenge of how closely to continue to harmonize its regulations with those of the EMA which some UK critics say would allow EMA to continue to dictate the content of the regulations.

As with much of the economic and political adjustments being made during the transition period after Brexit, the one constant at this time seems to be uncertainty.

Sentry Hosts Local Congressman Hollingsworth and BIO Health Care Representatives

JULY 6, 2017 INDIANAPOLIS, IN

Sentry BioPharma Services recently hosted a round table discussion with Congressman Trey Hollingsworth (IN 9^th District) and representatives of BIO and the Indiana Health Industry Forum (IHIF). BIO organized the event as a part of its “535 Congressional Initiative 2017”.

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Sentry is a long standing corporate member of BIO.

IHIF is Indiana’s statewide trade association representing Indiana’s health science business community. The diverse members of the Indiana Health Industry Forum generate the collective voice of the state’s health and life science industry. IHIF’s mission is to connect key stakeholders to: enhance business networks, advocate for member interests, develop workforce skills, and provide strategic vision in the interest of growing the state’s health industry economy and reputation.

About Sentry: Sentry BioPharma Services is a biopharmaceutical contract service provider offering an exceptional regulatory history, flawless quality record and superior customer service with a global reach. Sentry’s FDA compliant packaging solutions and supply chain management services to global pharmaceutical, biotechnology and medical device firms ensure product integrity throughout the pharmaceutical supply chain.

Drug development and commercialization require continuous temperature monitoring and control. Sentry’s validated software, GMP storage and distribution facility, industry expertise and stringent quality standards support this objective throughout manufacturing, labeling, packaging, and temperature-sensitive storage and distribution.

For more information on how Sentry can help with your pharmaceutical supply chain needs contact us via email or by phone at 1-866-757-7400.

Emergency Preparedness and You

Many people are concerned about the possibility of a public health emergency such as a natural disaster, act of terrorism, or disease outbreak. You can take steps now to help you prepare for an emergency and cope if an emergency happens. To help you prepare, we’ve provided step-by-step actions you can take beforehand to protect yourself and your loved ones.

Gather Emergency Supplies

If a disaster strikes in your community, you might not have access to food, water, or electricity for several days. You may think that you will have enough time to run to the grocery store, but stores quickly sell out of important supplies following emergency warnings. Unfortunately, about half of adults in the United States do not have the resources and plans in place for a possible emergency. Preparing emergency kits for your family is an important step in keeping them safe and healthy during a disaster.

Pack an emergency supply kit. Here’s what you’ll need:

At Least a 3-day Supply of Food and Water

Water – one gallon per person, per day
Food – foods that are easy to make and won’t spoil, like canned soup, dry pasta, and powdered milk
Manual can opener
Basic utensils to prepare and serve meals

Health Supplies

3-day supply of all medicines, at a minimum
Medical supplies like syringes, a walking cane, or hearing aids with extra batteries

Personal Care Items

Soap
Toothbrush and toothpaste
Baby wipes
Contact lenses or glasses

Safety Supplies

First aid kit
Emergency blanket
Multipurpose tool (that can act as a knife, file, pliers, and screwdriver)
Whistle

Electronics:

The National Oceanic and Atmospheric Administration (NOAA) provides weather updates during emergencies. Look for a radio labeled “NOAA Weather Radio.”

Flashlight
Radio (battery-powered, solar, or hand-crank) for updates on the situation
Cell phone with chargers
Extra batteries

Documents

Keep copies of your important documents, cash, spare keys, and maps in your emergency supply kit.

Copies of important documents such as insurance cards and immunization records
Paperwork about any serious or ongoing medical condition
Your completed family emergency plan, complete with family and emergency contact information.

You should also keep

Extra cash
Maps of the area
Extra set of car keys and house keys

Taking Care of Others

You may need additional supplies to make sure the whole family is ready

For Children

Baby supplies like bottles, formula, baby food, and diapers
Games and activities for children

For Pets

Plan ahead so you’re ready to take care of your pet during an emergency.

Food and Water:
- A 3-day supply of food and water for each pet. A cat or a dog will generally need 1 gallon for three days.
- Bowls or bottles
- Manual can opener
Cleaning Supplies:
- Depending on the pet, you may need a litter box, paper towels, plastic trash bags, grooming items, and household bleach.
Health and Safety:
- Medicines and medical records stored in a waterproof container
- First aid kit with a pet first aid book
Transport supplies:
- A sturdy leash, harness, and carrier to transport pets safely. A carrier should be large enough for the animal to stand comfortably, turn around, and lie down. Your pet may have to stay in the carrier for several hours.
Comfort Items:
- Pet toys and the pet’s bed, if you can easily bring it, to reduce stress.
Paperwork:
- Current photos and descriptions of your pets to help others identify them, and to prove that they are your pets, in case you become separated from them.
- Information on feeding schedules, medical conditions, behavior problems, and the name and telephone number of your veterinarian in case you have to board your pets or place them in foster care.

Keep these tips in mind!

Check and replace your supplies throughout the year.

Personalize

Every family is unique. You may have emergency needs not included in this list. Also, remember to update your kit according to changing needs of your family.

Be sure it’s ready to use

In a disaster situation, you may need to get your emergency supply kit quickly, whether you are sheltering at home or evacuating.

Once you have gathered your supplies, pack the items in easy-to-carry containers.
Clearly label the containers and store them where you can reach them easily.
Remember that certain items, like medications and paper documents, need to be kept in waterproof containers.

Keep it Fresh

Check the expiration dates on food, water, medicine, and batteries at least two times per year. It’s extremely important that all items in your kit are functional at the time of an emergency.

Involve Children

Families can make emergencies less stressful by preparing in advance and working together as a team. Ask your kids to think of items that they would like to include in an emergency supply kit, such as books, games, and pre-packaged foods.

Your kids can mark the dates on a calendar for checking emergency supplies. Tell them to remind you when it’s time to check the supplies.
Include kids in planning and creating disaster kits for family pets.

Know Your House

Find out where your gas, electric, and water shut-off locations are, and how to turn them off.

Prepare For Everywhere

Emergencies can happen anywhere. Remember to prepare supplies for home, work, and vehicles.

For more information about how Sentry can help optimize your solutions for biopharmaceutical product storage, distribution, packaging, project management and commercial fulfillment, contact Sentry via email or by phone at 1-866-757-7400.

PIC/S Committee Meeting

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee met recently on February 9-10, 2017.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as a non-binding, informal co-operative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any authority having a comparable GMP inspection system. PIC/S presently comprises around 50 participating authorities coming from all over the world (Europe, Africa, America, Asia and Australasia) including the U.S. FDA, Australia’s Therapeutic Goods Administration (TGA), Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA), and the EMA is a recognized partner of PIC/S working closely with the group to provide training and develop harmonized guidance documents. A committee of the participating authorities’ representatives (PIC/S Committee) supervises the organization’s activities and all decisions are taken unanimously.

PIC/S intent is to harmonize inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors. It also aims at facilitating cooperation and networking between competent authorities, regional and international organizations, thus increasing mutual confidence.

At the meeting in February, the PIC/S Committee reviewed a strategic plan (Road Map) for 2017-2019 which includes an objective to and ensure the full implementation of the PIC/S Inspectorates’ Academy (PIA).

The PIA is a PIC/S initiative to set up a web-based educational center under the PIC/S umbrella, which aims at harmonizing and standardizing GMP training at an international level through a certified qualification system. PIA delivers not only general or advanced training but also serves as a platform for discussion and sharing among regulators. It offers a single point of access to all PIC/S training activities and is being implemented in various stages.

The training of GMP inspectors has been at the core of PIC/S activities since its inception, however, PIC/S has also opened some of its training tools to inspectors active in other areas such as Good Distribution (GDP) and Good Clinical Practices (GCP).

In addition to the PIA, PIC/S offers an annual Training Seminar for inspectors, with each Seminar dealing with a specific topic. The Seminars are hosted by a different PIC/S regulatory authority each year and results in the setting up of a Drafting Group, which develops new or amends existing GMP guidance documents.

Other avenues for training and exchange supported by the organization include the PIC/S Joint Visits Programme which teams up inspectors from three different countries to observe GMP inspections in each country, as well as “Expert Circle” groups to enable inspectors to discuss and exchange information on specific technical areas of GMP, develop draft guidance documents, and to provide for training opportunities in their field of expertise. Expert Circles on Human Blood, Tissues, Cells and Advanced Therapy Medicinal Products (ATMPs), Computerised Systems, Active Pharmaceutical Ingredients (APls), Good Distribution Practices (GDP) and Quality Risk Management (QRM) are currently active and meet regularly.

FDA approves drug to treat Parkinson’s Disease

The focus of our post this week is Parkinson’s Disease and treatment. Therefore, we are sharing this article from the FDA concerning its new drug approval of Xadago.

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremors and difficulty walking.

“Parkinson’s is a relentless disease without a cure,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, though it can occur earlier, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement – such as eating, writing, and shaving. Early symptoms of the disease are subtle and occur gradually. In some people, Parkinson’s disease progresses more quickly than in others.

The efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing “off” time. Those receiving Xadago experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment.

In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during “on” time than before treatment.

Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).

Serious, but less common, risks include the following: exacerbated high blood pressure (hypertension); serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia (fever) and confusion; and retinal pathology.

The FDA granted approval of Xadago to Newron Pharmaceuticals.

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