Your source for the latest industry trends and drug information news.
Volume 4 | Issue 17
September 1, 2022
Contributors:
Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate
On August 19, 2022, Axsome Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) approved AuvelityTM (dextromethorphan HBr – bupropion HCl) for the treatment of adults with major depressive disorder (MDD). MDD is a common, disabling disorder characterized by sadness, loss of interest in activities, sleep disturbances and changes in appetite. Bupropion, one of the ingredients of AuvelityTM, is a commonly used medication for the treatment of MDD, but the addition of a second ingredient allows for the synergistic effects of two different mechanisms of action to improve response. In clinical trials, AuvelityTM improved depressive symptoms as early as one week into treatment. Symptom response to traditional antidepressant medications often takes six to eight weeks, so more rapid improvement may be advantageous in some patients. The most common side effects seen with AuvelityTM include dizziness, headache, diarrhea, drowsiness, dry mouth and sexual dysfunction. AuvelityTM should not be used in individuals with a seizure disorder or eating disorder, and it is not approved for use in patients younger than 18 years. AuvelityTM is expected to be available later this year.
On August 22, 2022, the FDA announced that Hospira voluntarily recalled one lot of Propofol Injectable Emulsion due to the presence of visible particulates. Propofol is an intravenous medication used as a general anesthetic and sedative, typically in the hospital setting. The use of the affected vials could increase a patient’s risk of serious adverse events caused by blockage of the blood vessels by the particulates. Along with this, there is greater potential for transmission of infectious diseases or hypersensitivity reactions. These single-use vials of propofol were distributed to wholesalers and hospitals in the United States from July 16, 2020 through July 24, 2020. Facilities with existing inventory of the recalled lot have been notified and are advised to discontinue use and stop distribution. Adverse reactions relating to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program. To date, Hospira has not received reports of any adverse events relating to this recall.
On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 into law. This law offers many health provisions aimed at lowering out-of-pocket drug costs and removing financial barriers to quality health care, primarily for Medicare beneficiaries. First, it allows the federal government to negotiate prices for high-cost drugs, such as brand name only medications and biologics without a biosimilar equivalent. It also requires drug manufacturers to pay rebates on medications if the prices increase faster than the rate of inflation. In addition, out-of-pocket spending for Medicare recipients will be reduced through limits on increases in Medicare premiums and elimination of coinsurance above the catastrophic threshold. The new law will also cap copayments of insulin to $35 per month and remove cost-sharing for adult vaccines covered under Medicare Part D. Lastly, the new law expands eligibility for full Part D low-income subsidies (LIS) to members with incomes up to 150% of the poverty line. These initiatives will be phased in starting in 2023 and will be fully implemented in 2029.
New Indication: MYFEMBREE® (relugolix, estradiol, norethindrone acetate) Oral tablet approved for once daily treatment of moderate to severe pain associated with endometriosis in pre-menopausal women. [8/5/2022 – MYOVANT SCIENCES]
New Formulation: CALQUENCE® (acalabrutinib) Oral tablet approved for treatment of mantle cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma in adult patients. [8/3/2022 – Orphan Drug – ASTRAZENECA]
