The FDA has approved subdermal implants of the partial opioid agonist buprenorphine (Probuphine – Titan) for maintenance treatment of opioid dependence in patients stabilized on low to moderate doses of transmucosal buprenorphine. Probuphine was designed to provide continuous low levels of buprenorphine for 6 months and to safeguard against illicit use of the drug.

The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal. It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy.

The FDA has approved Vaxchora (PaxVax), a single-dose, oral, live-attenuated cholera vaccine, to protect against disease caused by Vibrio cholerae serogroup O1 in adults 18-64 years old traveling to cholera-affected areas. Vaxchora is the only cholera vaccine available in the US. A whole-cell killed injectable vaccine was previously approved, but is no longer available in the US.

The FDA has approved use of Exablate Neuro (Insightec) for unilateral thalamotomy to treat medication-refractory essential tremor in patients ≥22 years old. Exablate Neuro uses magnetic resonance-guided focused ultrasound (MRgFUS) to create lesions in the ventral intermediate nucleus of the thalamus. MRgFUS is also approved in the US for treatment of uterine fibroids and for pain palliation of bone metastases.

The FDA has approved abaloparatide (Tymlos – Radius Health), a synthetic analog of human parathyroid hormone related peptide, for treatment of postmenopausal women with osteoporosis who are at high risk for fracture. Abaloparatide is the second parathyroid hormone receptor agonist to be approved for this indication; teriparatide (Forteo – Lilly), a recombinant parathyroid hormone analog, was the first. They are the only drugs approved for treatment of osteoporosis that stimulate bone formation. Other drugs used for this indication inhibit bone resorption.

The FDA has approved edaravone (Radicava – Mitsubishi Tanabe Pharma) for treatment of amyotrophic lateral sclerosis (ALS). It is the second drug to be approved in the US for this indication; riluzole (Rilutek, and generics) was approved in 1995. Edaravone was approved for treatment of ALS as Radicut in Japan and South Korea in 2015. It has been used in Japan and other Asian countries since 2001 for treatment of acute ischemic stroke.

The FDA has approved obiltoxaximab (Anthim – Elusys Therapeutics), a toxin-targeting monoclonal antibody, for treatment of inhalational anthrax in combination with antibacterial drugs and prophylaxis of inhalational anthrax when other therapies are unavailable or inappropriate. Raxibacumab, another monoclonal antibody, was approved earlier for the same indication. Like raxibacumab, obiltoxaximab is being manufactured only for the CDC national stockpile and is not available for commercial sale.

Interim results of a double-blind, placebo-controlled trial suggest that off-label use of the anticholinergic drug oxybutynin may reduce the frequency and severity of hot flashes in women with breast cancer. Extended-release oral oxybutynin (Ditropan XL, and generics) has been shown to reduce the frequency and severity of hot flashes in healthy menopausal women.

The FDA has approved Inbrija (Acorda), an orally inhaled dry-powder formulation of levodopa, for intermittent treatment of "off" episodes in patients with Parkinson's disease (PD) being treated with carbidopa/levodopa (Sinemet, and others).

The antisense oligonucleotide viltolarsen (Viltepso – NS Pharma) has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have mutations of the dystrophin gene that are amenable to exon 53 skipping (DMD-53). It is the second drug to be approved for this indication; the antisense oligonucleotide golodirsen (Vyondys 53) was approved in 2019.