The FDA has approved stiripentol (Diacomit – Biocodex) for treatment of seizures in patients ≥2 years old with Dravet syndrome who are also taking clobazam (Onfi). Stiripentol, which has been available in Europe, Canada, and Japan for many years, is the second drug to be approved in the US for this indication; cannabidiol oral solution (Epidiolex), a purified marijuana product, was the first.

Minoxidil 2% topical solution (Rogaine - Upjohn) has been available in the USA since 1988 for treatment of androgenetic alopecia (Medical Letter, 29:87, 1987). Although available only by prescription, it is advertised on television to the general public.

Eletriptan hydrobromide (Relpax Pfizer) is now available in the US for oral treatment of migraine headache in adults. It is the seventh serotonin 5-HT1B/1D-receptor agonist (triptan) to be approved by the FDA for this indication. This review describes the pharmacokinetics, adverse effects, drug interactions and recommended dosage of eletriptan. Clinical trials comparing the new drug to placebo and to sumatriptan are presented. A dosage and cost table for all the triptans available in the US is also included. The review concludes with an overall assessment of eletriptan's efficacy and...

The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations. Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg. NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult outpatients.

The FDA has approved an oral extended-release formulation of gepirone (Exxua – Fabre-Kramer), a selective 5-HT_1A receptor agonist, for treatment of major depressive disorder (MDD) in adults. Gepirone was originally developed decades ago for treatment of anxiety and depression, but it was not approved by the FDA for such use. Gepirone is structurally related to buspirone, which is FDA-approved for treatment of anxiety.

The FDA has approved a 0.3% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of plaque psoriasis in patients ≥12 years old. Roflumilast is the first topical PDE4 inhibitor to be approved by the FDA for this indication; crisaborole (Eucrisa), another topical PDE4 inhibitor, is approved for treatment of atopic dermatitis. Oral roflumilast (Daliresp) is approved for treatment of chronic obstructive pulmonary disease.

The FDA has approved suzetrigine (Journavx – Vertex), a selective sodium channel blocker, for oral treatment of moderate to severe acute pain in adults. Suzetrigine is the first sodium channel blocker to be approved in the US for this indication and the first oral nonopioid drug to be approved for treatment of pain in over 25 years.

The FDA has approved the opioid agonist hydromorphone in a once-daily extended-release (ER) oral tablet formulation (Exalgo – Covidien) for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, long-term therapy. Another hydromorphone ER formulation (Palladone – Purdue) was available previously, but was withdrawn from the market because taking it with alcohol could interfere with the extended-release mechanism and lead to rapid release of potentially lethal amounts of the drug ("dose-dumping").

Almotriptan (Axert - Pharmacia), and Frovatriptan (Frova - Elan) have been approved by the FDA for oral treatment of migraine headache (Drugs of Choice from The Medical Letter 2001, page 131.).

The FDA has approved an extended-release oral formulation of the opioid agonist hydrocodone (Zohydro ER – Zogenix) for management of pain severe enough to require continuous, long-term therapy and for which alternative treatment options are inadequate. Zohydro ER is the first single-ingredient hydrocodone product to be marketed in the US. Hydrocodone has been available for years in combination with acetaminophen (Vicodin, and others) or ibuprofen (Vicoprofen, and others).