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Pulse Newsletter

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

Volume 5 | Issue 11
July 1, 2023

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate

Clinical Pharmacy Update

Linzess® Approved for Pediatric Functional Constipation

The U.S. Food and Drug Administration (FDA) announced their approval of Linzess® (linaclotide) capsules for the treatment of pediatric functional constipation, a condition commonly experienced by children. Linzess® is the first treatment to be approved for this indication. It was previously approved to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adult patients. Linzess® works by increasing fluid in a patient’s intestines, accelerating bowel movements and calming associated pain. Its efficacy in treating functional constipation in pediatric patients ages 6-17 was established using the results of a 12-week clinical trial in this population along with a data review from trials in adult patients with CIC. To be eligible for the pediatric clinical trial, participants were required to have fewer than three spontaneous bowel movements (SBMs) per week along with history of either voluntary stool retention, large diameter stools, one episode of fecal incontinence per week, painful bowel movements or large fecal mass present in the rectum. Efficacy was demonstrated as participants receiving Linzess® experienced a greater improvement in their average number of SBMs per week compared to those receiving placebo. Diarrhea is the most common adverse reaction with Linzess®, and patients experiencing this side effect are advised to discontinue use and rehydrate if diarrhea is severe. Linzess® is not approved for children under age 6, and it has a black box warning to avoid its use in patients less than 2 years old.

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Drug Safety

Harvard Group Recalls One Lot of Dronabinol and Ziprasidone 

On June 13, 2023, the Harvard Drug Group, LLC announced a voluntary recall of a single lot of ziprasidone hydrochloride 20mg capsules and dronabinol 2.5mg capsules at the consumer level due to a labeling mix-up. This recall follows a consumer report of the presence of blister packs of dronabinal 2.5mg capsules in unit dose cartons labeled as ziprasidone hydrochloride 20mg. Both products are labeled with lot T04769 and have an expiration date of 12/2024. Ziprasidone is used in the treatment of schizophrenia and bipolar disorder. Dronabinol is used for the treatment of nausea and vomiting due to chemotherapy as well as anorexia associated with weight loss in patients with AIDS. Mistakenly taking dronabinol instead of prescribed ziprasidone will result in a patient missing their medication and the potential for an exacerbation of underlying heath issues such as agitation, delirium, aggression, bipolar disorder or schizophrenia. The dronabinol dose could also impair mental or physical abilities, worsening symptoms of mental illness disorders and limiting ability to drive or operate machinery. To date, there have been no reports of adverse events related to this recall. Harvard Drug Group, LLC is notifying wholesalers and distributors of this recall and advising consumers to stop using the affected product and contact their health care provider. Adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program.

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From the Pharmaceutical Industry

Paxlovid™ Receives FDA Approval Following Completion of EUA

On May 25, 2023, the FDA granted approval to Paxlovid™ for the treatment of mild to moderate COVID-19 infections in adult patients who may be at risk of progressing to severe disease. Paxlovid™ originally became available under emergency use authorization (EAU) in 2021, and now it is the first oral antiviral to receive full FDA approval for the treatment of COVID-19. Doses manufactured under the EUA will still be available through the U.S. Department of Health and Human Services to ensure continued access for adults as well as eligible children between ages 12-18 who are not covered by the recent FDA approval. Paxlovid™ was tested in the EPIC-HR trial, studying its efficacy in non-hospitalized, symptomatic adult patients with a confirmed SARS-CoV-2 infection who were not previously vaccinated. The study included adults 18 years and older with prespecified chronic medical conditions or risk factors, as well as patients 60 years and older regardless of risk factor status. Paxlovid™ significantly reduced the rate of COVID-19 hospitalizations or death during the 28 days following treatment. In the study, 977 participants received Paxlovid™, with only 0.9% experiencing hospitalization or death. Of the 989 patients receiving placebo, 6.5% experienced hospitalization or death. In a similar clinical trial of vaccinated adults, Paxlovid™ reduced hospitalizations or death in patients with at least one risk factor for progression to severe COVID-19. Diarrhea and impaired sense of taste are the most common side effects of Paxlovid™. The FDA is providing prescribers with their authorized Fact Sheet for Health Care Providers to reduce the risk of any significant drug-drug interactions when prescribing Paxlovid™. Health care providers are encouraged to assess a patient’s current medications and determine if any potential interactions can be managed and/or if the benefits of the treatment outweigh the risks.

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FDA Approvals

New FDA Approvals

New Drug: Opvee® (nalmefene hydrochloride)

Nasal spray approved for the emergency treatment of known or suspected opioid overdose caused by natural or synthetic opioids in adults and adolescents 12 years and older. [05/22/2023 – OPIANT PHARMS]              

New Drug: Brixadi™ (buprenorphine)

Extended-release subcutaneous injection administered weekly or monthly for the treatment of moderate to severe opioid use disorder in patients who are already being treated with buprenorphine or who have initiated treatment with a single dose of transmucosal buprenorphine. [05/23/2023 – BRAEBURN]

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New Generics

New Generics Entering the Marketplace

Prezista® (darunavir)

Indication: Co-administered with ritonavir in the treatment of human immunodeficiency virus (HIV) infection in adult and pediatric patients 3 years and older.

Dosage Form/Strength: 600mg and 800mg oral tablets

Average Wholesale Price (AWP): Generic = $2,262 | Brand = $2,514