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 the oral GABA_A receptor modulator zuranolone (Zurzuvae – Sage Therapeutics/Biogen) for treatment of postpartum depression (PPD). Zuranolone is the second drug to be approved for this indication; brexanolone (Zulresso), another GABA_A receptor modulator, was approved for IV treatment of PPD in 2019.

The FDA has approved two subcutaneously injected calcitonin gene-related peptide (CGRP) antagonists, fremanezumab-vfrm (Ajovy – Teva) and galcanezumab-gnlm (Emgality – Lilly), for migraine prevention in adults. Fremanezumab and galcanezumab are the second and third subcutaneously injected monoclonal antibodies that target the CGRP pathway to be approved by the FDA for this indication; erenumab-aooe (Aimovig), which targets the CGRP receptor, was the first.

The FDA has approved eptinezumab-jjmr (Vyepti – Lundbeck), a calcitonin gene-related peptide (CGRP) antagonist administered IV once every 3 months, for migraine prevention in adults. It is the fourth monoclonal antibody to be approved for this indication; erenumab (Aimovig), fremanezumab (Ajovy), and galcanezumab (Emgality), which are all given subcutaneously once monthly (fremanezumab can also be given once every 3 months), were approved earlier.

Atogepant (Qulipta – Abbvie), an oral small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant"), has been approved by the FDA for prevention of episodic migraine in adults. It is the second oral CGRP receptor antagonist to be approved in the US for this indication; the first was rimegepant (Nurtec ODT), which is also approved for acute treatment of migraine. Parenteral CGRP monoclonal antibodies are approved for prevention of migraine (see Table 3).

Elinzanetant (Lynkuet – Bayer), a first-in-class neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Fezolinetant (Veozah), an NK3 receptor antagonist, was approved for the same indication in 2023.

Previously approved by the FDA for treatment of depression, general anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia, duloxetine (Cymbalta – Lilly) has now also been approved for treatment of chronic musculoskeletal pain.

The FDA has approved erenumab-aooe (Aimovig – Amgen/Novartis), a once-monthly, subcutaneously-injected, monoclonal antibody against the calcitonin gene-related peptide receptor, for preventive treatment of migraine in adults. It is the first drug in its class to be approved by the FDA.

The motor symptoms of Parkinson's disease (PD) are caused primarily by degeneration of dopaminergic neurons in the substantia nigra. The nonmotor symptoms of the disease are thought to be caused by degeneration of other neurotransmitter systems. No disease-modifying drugs are available for treatment of PD.

The FDA has approved vorapaxar (Zontivity – Merck), an oral protease-activated receptor-1 (PAR-1) antagonist, for use with aspirin and/or clopidogrel to reduce the risk of thrombotic cardiovascular events in patients with peripheral arterial disease or a history of myocardial infarction (MI). It is the first PAR-1 antagonist to be approved by the FDA.