The FDA has approved Tonmya (Tonix), a sublingual tablet formulation of the skeletal muscle relaxant cyclobenzaprine, for treatment of fibromyalgia in adults. Cyclobenzaprine is available in immediate-release tablets and extended-release capsules for short-term treatment of muscle spasms and has been used off-label for treatment of fibromyalgia.

Our recent article entitled Lumateperone (Caplyta) for Adjunctive Treatment of Depression should have included urinary incontinence among the adverse effects associated with use of second-generation antipsychotic drugs. Urinary incontinence has been reported with both first- and second-generation antipsychotics. Possible causes include the anti-alpha-adrenergic, antidopaminergic, and anticholinergic effects of these drugs, as well as sedation. In an observational study in 200 women 20-40 years old, urinary incontinence was reported by 29% of those taking antipsychotic drugs and by 13%...

The FDA has approved Cobenfy (BMS), an oral fixed-dose combination of the muscarinic agonist xanomeline and the peripheral muscarinic antagonist trospium chloride, for treatment of schizophrenia in adults. It is the first antipsychotic drug to be approved in the US for treatment of schizophrenia that does not block dopamine receptors. This is the first approval for xanomeline; trospium has been available for many years for treatment of overactive bladder.

The FDA has approved Zunveyl (Alpha Cognition), a delayed-release formulation of the prodrug benzgalantamine, for treatment of mild to moderate dementia of Alzheimer's disease (AD). Immediate- and extended-release formulations of the acetylcholinesterase inhibitor galantamine have been available in the US for years for treatment of AD.

View the Comparison Table: Inhaled Drugs for Treatment of COPD

Anxiety disorders (generalized anxiety disorder, panic disorder, social anxiety disorder, and various phobias) are the most common form of psychiatric illness. They can be treated effectively with cognitive behavioral therapy (CBT) and/or pharmacotherapy.

Irritable bowel syndrome (IBS) is a common disorder characterized by recurrent abdominal pain and altered bowel habits, often accompanied by bloating. IBS is classified by its predominant bowel symptom: constipation (IBS-C), diarrhea (IBS-D), mixed type (IBS-M), or unclassified (IBS-U). Since the exact cause of IBS is unknown, the goal of treatment is symptom control. Some over-the-counter (OTC) products and prescription drugs for IBS are listed in Tables 1-4. The safety of these drugs during pregnancy and lactation is described in Table 5 (online only).

Cognitive behavioral therapy for insomnia (CBT-I) is recommended for initial treatment of chronic insomnia. CBT-I includes stimulus control, sleep education and hygiene, sleep restriction, relaxation training, and cognitive therapy. When CBT-I alone is not effective, pharmacologic treatment should be added.

Nadofaragene firadenovec-vncg (Adstiladrin – Ferring), an adenoviral vector-based gene therapy, has been approved by the FDA for treatment of adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. It is the first adenoviral vector-based gene therapy to be approved in the US for this indication. The immune checkpoint inhibitor pembrolizumab (Keytruda) was approved for the same indication in 2021.

The FDA has approved gepotidacin (Blujepa – GSK), a triazaacenaphthylene bacterial type II topoisomerase inhibitor, for oral treatment of uncomplicated urinary tract infections (uUTI) in female patients ≥12 years old who weigh ≥40 kg. Gepotidacin is the first triazaacenaphthylene antibiotic to be approved in the US.