The FDA has approved the oral, once-daily, second-generation antipsychotic brexpiprazole (Rexulti – Otsuka/Lundbeck) for treatment of schizophrenia and as an adjunct to antidepressants for treatment of major depressive disorder (MDD). Aripiprazole (Abilify), a structurally similar second-generation antipsychotic also comarketed by Otsuka (with BMS), recently became available generically.

Levalbuterol, the R-isomer of racemic albuterol, has been approved by the FDA for prevention and treatment of bronchospasm in patients at least 12 years old.

The FDA has approved osilodrostat (Isturisa – Recordati), a cortisol synthesis inhibitor, for oral treatment of adults with Cushing's disease when surgical resection of the pituitary adenoma is not an option or has not been curative. Osilodrostat is the first cortisol synthesis inhibitor to be approved in the US for this indication. Other oral steroidogenesis inhibitors such as ketoconazole and metyrapone have been used off-label for this indication for many years.

The FDA has approved sotagliflozin (Inpefa – Lexicon), an oral sodium-glucose cotransporter 1 and 2 (SGLT1/2) inhibitor, to reduce the risk of hospitalization for heart failure (HF), urgent HF visits, and cardiovascular death in adults with either HF (with any left ventricular ejection fraction [LVEF]) or type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular risk factors. Sotagliflozin is the first dual SGLT1/2 inhibitor to be approved in the US. Unlike SGLT2 inhibitors, it is not FDA-approved to improve glycemic control in adults with type 2 diabetes....

Elafibranor (Iqirvo – Ipsen), a peroxisome proliferator-activated receptor (PPAR) agonist, has been granted accelerated approval by the FDA for treatment of primary biliary cholangitis (PBC) in adults. It is indicated for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso, and others) in patients with an inadequate response to UDCA alone and as monotherapy in those unable to tolerate UDCA.

Many different drugs are used for treatment of osteoarthritis pain, but none of them prevent progression of the disease. Nonpharmacologic approaches including weight management, exercise, tai chi, physical therapy, assistive devices, and total joint arthroplasty can also be used. The American College of Rheumatology (ACR) has published new guidelines for the management of osteoarthritis of the hip, hand, and knee.

Fibrates, niacin and fish oil are promoted for treatment of hypertriglyceridemia. HMG-CoA reductase inhibitors (statins) can lower elevated serum concentrations of triglycerides, but less so than fibrates, niacins or fish oil. Lifestyle changes such as weight reduction, exercise and decreasing alcohol intake can also lower serum triglyceride levels and should be tried first.

Lasmiditan (Reyvow – Lilly), an oral serotonin (5-HT_1F) receptor agonist, and ubrogepant (Ubrelvy – Allergan), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, have been approved by the FDA for acute treatment of migraine with or without aura in adults.

Sumatriptan (soo ma trip' tan; Imitrex - Glaxo), a serotonin (5-HT) agonist, is now available in Canada and may soon be available in the USA for oral or parenteral treatment of migraine headache. The parenteral formulation is designed for patients to inject themselves subcutaneously. Sumatriptan is not recommended for prophylactic use.

The FDA has approved the marketing of Vimovo (AstraZeneca), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) naproxen and the proton pump inhibitor (PPI) esomeprazole, for symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk for NSAID-associated ulcers.