An oral formulation of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Rybelsus – Novo Nordisk) has been approved by the FDA for once-daily treatment of type 2 diabetes in adults. Semaglutide, which has been available in a subcutaneously-injected formulation (Ozempic) since 2017, is the first GLP-1 receptor agonist to become available for oral administration; the 4 other GLP-1 receptor agonists currently available in the US are administered by subcutaneous (SC) injection.

The FDA has approved pitolisant (Wakix – Harmony), a histamine-3 (H₃)-receptor antagonist/inverse agonist, for treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. It is the first H₃-receptor antagonist/inverse agonist to become available in the US and the first non-controlled substance to receive FDA approval for these indications. Pitolisant has been available in Europe since 2016.

The FDA has approved fenfluramine oral solution (Fintepla – Zogenix) for treatment of seizures in patients ≥2 years old with Dravet syndrome. It is the third drug to be approved for this indication. Stiripentol (Diacomit) and cannabidiol (Epidiolex), a purified product derived from marijuana, were approved earlier.

The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.

Ceftobiprole medocaril sodium (Zevtera – Innoviva Specialty Therapeutics), a new IV cephalosporin antibacterial drug, has been approved by the FDA for treatment of Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSIs), and community-acquired bacterial pneumonia (CABP) (see Table 1). It is the second cephalosporin with activity against methicillin-resistant S. aureus (MRSA) to be approved in the US; ceftaroline (Teflaro), which was approved for treatment of ABSSSIs and CABP in 2010, was the...

A new CDC guideline for prescribing opioids for pain recently became available. Nonopioid drugs for pain were reviewed in a previous issue.

The US Food and Drug Administration recently approved the marketing of a cervical cap (Prentif Cavity-Rim Cervical Cap - Lamberts Ltd, England), a contraceptive device that has been used in one form or another for many years (JP Koch, Contraception, 25:161, 1982). The cap is being distributed in the USA and Canada by Cervical Cap (CxC), Ltd, PO Box 38003-292, Los Gatos, CA 95031, telephone 408-358-6264; the distributor will make the caps available only to practitioners who have attended training seminars.

Captopril (Capoten - Bristol-Myers Squibb), an angiotensin-converting enzyme (ACE) inhibitor previously available for treatment of hypertension, has now been approved by the US Food and Drug Administration (FDA) for treatment of diabetic nephropathy in patients with insulin-dependent diabetes mellitus (IDDM). Diabetic nephropathy is the most common cause of end-stage renal disease in the United States.

Calcipotriene ointment 0.005% (calcipotriol; Dovonex - Westwood Squibb), a synthetic vitamin D 3 analog previously available in Europe and Canada, has now been approved by the US Food and Drug Administration (FDA) for treatment of moderate plaque psoriasis, the most common form of the disease.

Although lithium (Eskalith, and others) is the standard treatment for bipolar (manic-depressive) disorder, 20% to 40% of patients do not respond adequately or cannot tolerate its adverse effects (Medical Letter, 33:43, 1991). Results of recent studies suggest that valproate (Depakene - valproic acid; Depakote - divalproex sodium), a widely used anticonvulsant (Medical Letter, 31:1, 1989), might be an effective alternative. Other anticonvulsants, particularly carbamazepine (Tegretol, and others), have also been used as second-line drugs for treatment of mania and other psychiatric ...