The FDA has approved tramadol hydrochloride extended-release (Ryzolt – Purdue) for treatment of moderate to moderately severe chronic pain in adults. Tramadol is already available in another extended-release formulation (Ultram ER) and in immediate-release tablets alone (Ultram, and others) and combined with acetaminophen (Ultracet, and others).

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.

The FDA has approved an extended-release fixed-dose combination of dextromethorphan and bupropion (Auvelity – Axsome) for treatment of major depressive disorder (MDD) in adults.

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.

View the Comparison Table: Triptans for Migraine

The FDA has approved Symbravo (Axsome), an oral fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam and the 5-HT_1B/1D receptor agonist (triptan) rizatriptan (Maxalt, and generics), for acute treatment of migraine with or without aura in adults. It is the second combination of an NSAID and a triptan to be approved for migraine treatment. An oral fixed-dose combination of sumatriptan and naproxen (Treximet, and generics) is approved for use in patients ≥12 years old.

The FDA has approved Akynzeo (Helsinn/Eisai), an oral fixed-dose combination of the substance P/neurokinin 1 (NK1) receptor antagonist netupitant and the serotonin-3 (5-HT3) receptor antagonist palonosetron, for prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy in adults. Akynzeo is the first product to combine drugs from these two classes. Palonosetron (Aloxi) is also available as a single agent for prevention of chemotherapy-induced and postoperative nausea and vomiting. Netupitant is the second substance P/NK1 receptor antagonist to be...

Rasagiline (Azilect - Teva), a monoamine oxidase-type B (MAO-B) inhibitor, was recently approved by the FDA for once-daily oral treatment of Parkinson's disease (PD). It can be taken alone for treatment of early disease or with levodopa/carbidopa (Sinemet, and others) for advanced disease. Selegiline (Eldepryl, and others), the first MAO-B inhibitor marketed in the US, has been available since 1988; a new lower-dose disintegrating tablet (Zelapar) was recently approved.

An oral nonopioid analgesic is often sufficient for acute treatment of mild to moderate migraine pain without severe nausea or vomiting. A triptan is the drug of choice for treatment of moderate to severe migraine in most patients without vascular disease. Treatment of pain when it is still mild to moderate in intensity improves headache response and reduces the risk of recurrence.