The FDA has approved the oral second-generation antipsychotic drug brexpiprazole (Rexulti – Otsuka/Lundbeck) for once-daily treatment of agitation associated with dementia due to Alzheimer's disease (AD). Brexpiprazole is the first drug to be approved in the US for this indication. It is also approved for treatment of schizophrenia and as an adjunct to antidepressants for treatment of major depressive disorder.

The FDA has approved lemborexant (Dayvigo – Eisai), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. It is the second orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) was the first.

View the Comparison Table: Some Oral Antiseizure Medications

The FDA has approved daridorexant (Quviviq – Idorsia), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. Daridorexant is the third orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) and lemborexant (Dayvigo) were approved earlier.

The FDA has approved Gimoti (Evoke), a nasal spray formulation of the dopamine-2 (D₂) receptor antagonist metoclopramide, for relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide (Reglan, and generics) has been available for years in conventional and orally-disintegrating tablets and in an injectable formulation. It is the only drug that is FDA-approved for treatment of diabetic gastroparesis.

An oral formulation of testosterone undecanoate (Jatenzo – Clarus) has been approved by the FDA for treatment of adult men with conditions associated with a deficiency of endogenous testosterone, such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Jatenzo is not approved for treatment of low testosterone levels solely due to aging. It is the first oral testosterone formulation to be approved in the US.

The FDA has approved ensifentrine (Ohtuvayre – Verona), an inhaled phosphodiesterase (PDE) 3 and 4 inhibitor, for maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. It is the first dual inhibitor of PDE3 and PDE4 to be approved by the FDA, and the first inhaled drug with a new mechanism of action to be approved for treatment of COPD in more than 20 years.

Atrial fibrillation (AF) is the most common arrhythmia in the world. Risk factor modification, anticoagulation, rhythm control, and rate control are the four pillars of its management. American College of Cardiology/American Heart Association (ACC/AHA) guidelines on management of AF were updated recently.

Oriahnn (Abbvie), a fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist elagolix, the estrogen estradiol, and the progestin norethindrone acetate copackaged with elagolix alone, has been approved by the FDA for oral treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the first product to be approved in the US for this indication. Elagolix (Orilissa) has been available since 2018 for treatment of moderate to severe pain associated with endometriosis. The GnRH receptor antagonist...

The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults with schizophrenia or with manic or mixed episodes of bipolar I disorder. The addition of samidorphan is intended to mitigate the weight gain that occurs with olanzapine. This is the first FDA approval for samidorphan.