Your source for the latest industry trends and drug information news.
Volume 7 | Issue 12
June 15, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate, Xintian Wu, PharmD/MBA Candidate, and Jessica Lin PharmD/MBA Candidate
On June 3, 2025, Nubeqa® (darolutamide) received an expanded indication from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), a type of advanced prostate cancer that has spread from the prostate into other parts of the body. Nubeqa® was previously FDA-approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and as part of a combination treatment in adult patients with metastatic castration-sensitive prostate cancer (mCSPC) with docetaxel, a chemotherapy drug given intravenously (IV). The expanded indication in adult patients with mCSPC allows for use of Nubeqa® oral tablets without the coadministration of IV docetaxel, providing patients the opportunity to self-administer their medication at home. The recommended dose of Nubeqa® for treatment of mCSPC is 600mg taken by mouth twice daily with food.
The safety and efficacy of Nubeqa® single-drug therapy for the treatment of mCSPC was tested in a randomized, double-blind, placebo-controlled trial of 669 patients. The primary efficacy outcome was progression-free survival as evidenced using radiographic imaging. Compared to placebo, treatment with Nubeqa® resulted in a statistically significant improvement in patient outcome. Common side effects of Nubeqa® include fatigue, constipation, rash, high blood pressure and bleeding. Warnings and precautions for use of Nubeqa® include risk of fetal harm or loss of pregnancy if pregnant women are exposed to the drug. Nubeqa® may also cause serious side effects, such as ischemic heart disease (blockage of the arteries in the heart) and seizures. The manufacturer recommends patients contact their health care provider right away if they experience any of these serious side effects while receiving treatment with Nubeqa®.
On June 2, 2025, Amneal Pharmaceutical LLC announced a nationwide recall of three lots of sulfamethoxazole-trimethoprim 400mg/80mg oral tablets. The company received a product quality complaint noting that black spots were observed on the surface of the tablets, which was determined to be caused by microbial contamination from a fungus called Aspergillus. Aspergillus may cause serious or life-threatening infections, however, to date, there have been no reports of adverse events or illnesses linked to the contaminated lots of the medication. Sulfamethoxazole-trimethoprim is a combination antibiotic that is commonly used for the treatment of various susceptible bacterial infections, such as urinary tract infections, ear infections and acute bronchitis. The recalled lots were distributed between 12/4/24 and 5/15/25 and Ameal is notifying customers by UPS to arrange for the return of all recalled products. Any adverse events may be reported to the FDA’s MedWatch Adverse Event Reporting program online.
Moderna, a U.S.-based pharmaceutical company focused on vaccine development, will be launching a new vaccine for the prevention of COVID-19 this fall. The vaccine, mNEXSPIKE®, was recently approved by the FDA for limited use in adults 65 and older and individuals 12 and older with an underlying condition, such as chronic lung disease, diabetes or heart disease that puts them at higher risk for more severe outcomes from COVID-19. mNEXSPIKE® will be available as a COVID-19 vaccine option for qualifying individuals who have previously been vaccinated against COVID-19. The new vaccine will be offered as a low-dose option in addition to Moderna’s original COVID-19 vaccine, Spikevax®, which is FDA approved in individuals 12 and older. Side effects of mNEXSPIKE® are similar to those seen with other COVID-19 vaccines, including redness or swelling at the injection site, fever, headache and chills. In addition to this new vaccine, Spikevax® will be updated to more closely target one of the newer variants of the COVID-19 virus, LP.8.1. Other COVID-19 vaccine options, including Pfizer’s Comirnaty® and Novavax’s COVID-19 vaccine, will also be available in the 2025-2026 season.
New Drug: Tryptyr® (acoltremon)
Ophthalmic solution approved to treat the signs and symptoms of dry eye disease. [5/28/2025 - Alcon Laboratories Inc]
Complera® (emtricitabine / rilpivirine / tenofovir disoproxil fumarate)
Indication: For the treatment of human immunodeficiency virus-1 (HIV-1) infection in patients 12 years and older who have not received any HIV treatment and have a viral load of less than or equal to 100,000 copies/mL at the start of therapy. It is also used to replace current HIV medications in certain patients whose infection is well controlled with a viral load of less than 50 copies/mL.
Dosage Form/Strength: 200mg/25mg/300mg combination oral tablet
Average Wholesale Price (AWP): Generic = $4,374 | Brand = $4,604
