DEA temporarily extends telehealth for prescribed controlled substances
On May 10, 2023, the Drug Enforcement Administration (DEA) published in the Federal Register a temporary rule, effective the following day, to extend COVID-19 telemedicine flexibilities for prescription of controlled medications. The rule ensures temporary maintenance of pandemic-era flexibilities through November 2023 while the DEA works with the US Department of Health and Human Services to establish a plan for the future of controlled substance prescribing. These flexibilities were previously set to expire on May 11, 2023, at the end of the COVID-19 public health emergency.
FDA advisory panel recommends approval of first OTC birth control pill
An independent panel of experts voted unanimously in favor of FDA approval for the first over-the-counter (OTC) birth control pill, Perrigo's Opill(R) norgestrel tablet 0.075 mg. The panel recommended that Opill be approved as safe, effective, and easy for women of all ages to use appropriately.
Opill, which contains only progestin, is a safer option than pills that contain both progestin and estrogen. Combination pills are contraindicated in more women with certain medical conditions than progestin-only pills. However, progestin-only pills are less effective if not taken at the same time daily, one issue the advisory panelists had to consider. The panel also needed to consider whether women who might take Opill-especially adolescents or those with limited literacy-would potentially have difficulty understanding labeling instructions, as well as whether women with breast cancer or undiagnosed abnormal vaginal bleeding would be aware that they should avoid taking it.
OTC oral contraceptives are available in Central America, South America, Asia, Africa, and Europe. The FDA is expected to make a final decision regarding Opill approval in the US this summer.
FDA approves RSV vaccine
The first respiratory syncytial virus (RSV) vaccine has been approved for use in the US by the FDA. The vaccine, Arexvy, is approved for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older. Arexvy is a product of GlaxoSmithKline Biologicals.
Each year, RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 years of age and older. The FDA approved Arexvy in individuals 60 years of age and older based on an analysis of data from an ongoing 3-year clinical study. Data regarding use of a single dose of Arexvy from the first RSV season of the study were available for FDA review. The vaccine significantly reduced the risk of developing RSV-associated LRTD, by a total of 82.6%, and reduced the risk of developing severe RSV-associated LRTD by 94.1%. Among all clinical trial participants, atrial fibrillation within 30 days of vaccination was reported in 10 individuals who received Arexvy and 4 who received placebo.
Drug approved for agitation associated with dementia due to Alzheimer disease
The FDA approved Rexulti(R) (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer disease (AD); the drug is the first approved treatment option for this indication. Agitation in patients with AD-associated dementia is among the most persistent, complex, stressful, and costly aspects of care for these patients.
Rexulti's effectiveness for this indication was determined through two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies. In both studies, patients receiving 2 mg or 3 mg of Rexulti showed statistically significant and clinically meaningful improvements in agitation survey tool scores.
Rexulti is a product of Otsuka Pharmaceutical Company Ltd. and Lundbeck Inc.