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.

The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have received accelerated approval by the FDA for use together for a fifth indication: treatment of unresectable or metastatic solid tumors with a BRAF V600E mutation in patients ≥6 years old who have progressed following prior treatment and have no satisfactory alternative treatment options. The combination is not approved for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition and dabrafenib is not approved for use in patients with wild-type BRAF...

The FDA now requires that the labels of all extendedelease stimulants used for treatment of attention-deficit/hyperactivity disorder (ADHD) include a warning about the risks of weight loss and other adverse effects associated with their use in children <6 years old. The labels of all stimulants used for treatment of ADHD already contain a boxed warning about the high risk of abuse and dependence associated with their use.

The potassium-competitive acid blocker vonoprazan (Voquezna – Phathom), which was approved earlier for treatment of erosive esophagitis, has now been approved by the FDA for relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection.

The FDA has approved Seglentis (Esteve/Kowa), an oral combination of tramadol hydrochloride, a weak opioid agonist and weak serotonin and norepinephrine reuptake inhibitor (SNRI), and celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), for use in adults with acute pain that is severe enough to require an opioid and for which alternative treatment options are inadequate.

View the Comparison Table: Some Oral Anticoagulants for VTE

The FDA has required a new warning in the label of the oral selective neurokinin 3 (NK3) receptor antagonist fezolinetant (Veozah) about the risk of hepatoxicity. The label of fezolinetant, which was approved by the FDA in 2023 for treatment of moderate to severe vasomotor symptoms due to menopause, already contained a warning about hepatic transaminase elevations associated with use of the drug.

The FDA has approved the second-generation antipsychotic drug lumateperone (Caplyta — Intra-Cellular Therapies) for adjunctive treatment of major depressive disorder (MDD) in adults. Lumateperone was approved earlier for treatment of schizophrenia and bipolar depression.

The opioid agonist tramadol is now available in an oral solution (Qdolo – Athena Bioscience) for management of pain severe enough to require an opioid and for which alternative treatment options are inadequate. Tramadol has been available for years in immediate-release tablets and capsules, extended-release capsules (Ultram, and others), and in a fixed-dose combination tablet with acetaminophen (Ultracet, and generics).

The FDA has approved Onyda XR (Tris), an extended-release (ER) oral suspension formulation of the alpha_2-adrenergic agonist clonidine, for use as monotherapy or as an adjunct to stimulant therapy for treatment of attention-deficit/hyperactivity disorder (ADHD) in children ≥6 years old. Clonidine ER tablets have been available for years for treatment of ADHD in children 6-17 years old.