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Pulse Newsletter

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

Volume 5 | Issue 18
October 15, 2023

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

Exxua™ Approved for the Treatment of Major Depressive Disorder

On September 22, 2023, the U.S. Food and Drug Administration (FDA) approved Exxua™ (gepirone hydrochloride) extended-release tablets as a novel treatment for major depressive disorder (MDD) in adult patients. More than 80 million Americans are affected by clinical symptoms of depression. Many patients treated with an antidepressant medication either do not achieve a satisfactory response or experience bothersome side effects, emphasizing the importance of developing new therapies. Exxua™ is the first new chemical entity (NCE) to selectively target serotonin 1A (5HT1A) receptors to relieve depressive symptoms. Activation of this receptor has been linked to the mediation of mood disorders and suicide risk. Most alternative treatment options target a variety of serotonin receptors, some of which are responsible for the side effects of those medications. By limiting the mechanism to a single serotonin receptor, Exxua™ has demonstrated a more favorable side effect profile. In clinical trials, Exxua™ showed no significant adverse effect on sexual function, blood pressure, heart rate, weight or liver function. This new approval will offer an effective new treatment option for adult patients with major depressive disorder who have been unable to tolerate alternative medications’ side effects. It is only approved for use in adults and has not been studied in pediatric patients. Exxua™ is expected to be available for patients in early 2024.

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Drug Safety

Nationwide Recall of ION* Sinus Products Due to Microbial Contamination

Biomic Sciences has announced their voluntary nationwide recall of all lots of ION* Sinus Support, ION* Sinus and Restore Sinus Spray due to the presence of microbial contamination. These products may have been purchased by consumers in retail stores or online, and they include ION* Sinus Support sold between September 2021 and September 2023, ION* Sinus sold between September 2019 and September 2021 and Restore Sinus Spray sold between June 2017 and September 2019. The microbes found in these products, Microbacterium sp., Fictibacillus sp., Bacillus sp. and Paenibacillus sp., are generally non-pathogenic but could still pose a risk to patients who recently underwent sinus or nasal surgery. Administration of these products to at-risk patients could potentially lead to severe adverse events resulting from bacteria and fungi being introduced into the body. At this time, there have been no reports of adverse events related to this recall. Consumers are advised to discontinue use and discard the product. Biomic Sciences will arrange a refund to individuals who provide a photo of the lot number on the bottle before discarding it. Patients should contact their physician if they experience any issues associated with this medication and also report them to the FDA’s MedWatch Adverse Event Reporting program.

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From the Pharmaceutical Industry

FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types

On September 29,2023, the FDA granted the first authorization to market a DNA test to identify genetic predisposition for certain cancer types. The Invitae Common Hereditary Cancers Panel is a diagnostic blood test designed to detect 47 gene variants associated with an increased risk of developing certain cancers. The Invitae panel identifies some significant genes such as those associated with breast and ovarian cancer (BRAC1 and BRAC2) and Lynch syndrome (MLH1, MSH2, MSH6, PMS2 and EPCAM). FDA’s De Novo premarket review pathway validated the test accuracy to be ≥ 99% for all tested variant types in over 9,000 clinical samples. Invitae does not identify or evaluate all genes associated with cancer predisposition. The test is only available through a health care provider. Some risks associated with the test are possible false positive or false negative results and misunderstanding of the results by patients. To mitigate this risk, patients should speak with a health care professional to interpret the results.

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FDA Approvals

New FDA Approvals

New Drug: Rivfloza (nedosiran)

Monthly subcutaneous injection approved to lower urinary oxalate levels in adults and children 9 years and older with primary hyperoxaluria type 1 (a rare genetic condition that impacts the kidneys) and relatively preserved kidney function. [09/29/23 – ORPHAN DRUG - NOVO NORDISK INC]

New Drug: Pombiliti™ (cipaglucosidase alfa-atga)

Intravenous infusion approved to treat late-onset Pompe disease (a rare genetic condition that results in muscle weakness and wasting) in adult patients weighing 88 lb (40 kg) or greater who are not improving on their current enzyme replacement therapy (ERT). [09/28/23 – ORPHAN DRUG - AMICUS THERAPEUTICS US, LLC]

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New Generics

New Generics Entering the Marketplace

Onexton®  (clindamycin phosphate and benzoyl peroxide) 

Indication: Used for the treatment of acne vulgaris in patients 12 years and older.

Dosage Form/Strength: 1.2%/3.75% topical gel

Average Wholesale Price (AWP): Generic = $694 | Brand = $868