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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 4 | Issue 3
February 1, 2022

Chief Author: Dana Ranallo, PharmD
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Provides Updates to COVID-19 Vaccine Recommendations

On January 3, 2022, the U.S. Food and Drug Administration (FDA) made several updates to the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. The EUA now allows individuals as young as 12 years old to receive a booster dose of the vaccine. Additionally, any individual who has received the Pfizer-BioNTech vaccine is now eligible to receive a booster dose as early as 5 months after completion of the initial 2-dose series. This update also now allows children ages 5-11 who have undergone solid organ transplant, or otherwise have an equivalent level of immunocompromise, to receive a third primary series dose of the Pfizer-BioNTech vaccine. This expands the previous FDA EUA, which allowed for a third primary series dose in immunocompromised individuals 12 and older. Pfizer has also begun a clinical trial to evaluate the efficacy of a new vaccine targeting the Omicron variant. While current data suggests that boosters provide a high level of protection against severe disease and hospitalization due to Omicron, there may be a need for an Omicron-specific vaccine in the future. On January 7, the FDA also updated the EUA for Moderna’s vaccine to allow for a booster dose at least 5 months after completion of the initial series, for individuals 18 and older. Complete information on the most up to date booster recommendations can be found on the Center for Disease Control and Prevention (CDC) website. The FDA continues to review new data as it becomes available and communicate with the public if any updates to the current recommendations are made. 

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Drug Safety

FDA Warning about Dental Problems Linked to Orally Dissolved Buprenorphine 

On January 12, 2022, the FDA released a Drug Safety Communication regarding dental problems associated with certain buprenorphine formulations that are dissolved in the mouth. Buprenorphine, a medication used for pain management and as a treatment for opioid use disorder (OUD), is available as tablets and films that are dissolved under the tongue or cheek, as well as other formulations like a skin patch, injection and implant. OUD is characterized by continuing use of opioids despite harmful consequences such as developing dependence and/or tolerance, problems with interacting with others and/or performing daily duties, exacerbations of mental/physical problems and increased chances of physical harm. Buprenorphine can be used to block the effects of other opioids to reduce or eliminate cravings and withdrawal symptoms, and may often be used in combination with the opioid blocking drug, naloxone. The use of buprenorphine, when combined with counseling and other behavioral therapies, greatly improves patients’ chances of survival and quality of life. The FDA has received reports of dental problems, including tooth decay, cavities, oral infections and loss of teeth, in patients using orally dissolvable formulations of buprenorphine, even in those with no history of dental issues. These reports have led the FDA to require a new warning to be added to the prescribing information and patient Medication Guides for these products, to discuss the risk of dental problems. The benefits of using buprenorphine products still greatly outweigh the risks, so it is important that individuals who are prescribed these medications continue to take them as directed by their health care provider. Suddenly stopping or changing the way you’re taking a buprenorphine product can result in withdrawal or relapse. Individuals who are using these medications are advised to seek out dental care services and have regular checkups while being treated. Steps can be taken to minimize and prevent the onset of any dental issues after administering the medication. After taking the medication, patients should take a large sip of water and gently swish around the teeth and gums before swallowing, and then wait at least one hour before brushing their teeth so that their mouth can return to normal and reduce the risk for damage. Patients and health care professionals should report any adverse events to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

FDA Approves Quviviq™ for Adult Insomnia

On January 7, 2022, the FDA approved Idorsia’s Quviviq™ (daridorexant) oral tablets for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Quviviq™ works by binding to the orexin receptor, thereby blocking wake-promoting chemical messengers, orexin A and orexin B, from binding to the receptor and ultimately decreasing the overactive wakefulness often experienced by individuals with insomnia. The approval was granted following results from a Phase 3 clinical trial program consisting of two studies which evaluated 1,854 adult patients with a diagnosis of insomnia who received either 10mg, 25mg, or 50mg of Quviviq™, or placebo, once daily in the evening. The primary endpoints of the program were Latency to Persistent Sleep (LPS) and Wake After Sleep Onset (WASO)which are objective measures for sleep induction and sleep maintenance, respectively. The secondary endpoint of the studies was patient-reported Total Sleep Time (sTST). Results showed that both the 25mg and 50mg dose of Quviviq™ significantly improved sleep onset, sleep maintenance and total reported sleep time when compared to placebo while the 10mg dose did not demonstrate improvement. The most common side effects associated with Quviviq™ were headache and fatigue. Quviviq™ should be taken 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening, and should not be taken more often than prescribed. Quviviq™ has been classified as a controlled substance by the FDA due to its potential to be abused or dependency and is expected to become available to patients in May 2022.

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FDA Approvals

New FDA Approvals

Novel Drug Approval: Cibinqo® (abrocitinib)
Oral tablets approved for the treatment of moderate-to-severe atopic dermatitis, also known as eczema, in adult patients who are not adequately controlled on or are not eligible for other treatment options, including biologics. [01/14/2022 – Priority Review – PFIZER INC]

Novel Drug Approval: Quviviq™ (daridorexant)
Oral tablets approved for the treatment of insomnia in adult patients who have trouble falling asleep and/or staying asleep. [01/07/2022 – IDORSIA PHARMACEUTICALS LTD]