The FDA has approved esketamine (Spravato – Janssen), an N-methyl-D-aspartate (NMDA) receptor antagonist, for intranasal treatment (in conjunction with an oral antidepressant) of adults with treatment-resistant depression (TRD). This is the first FDA approval for esketamine, which is the S-enantiomer of the intravenous anesthetic ketamine (Ketalar, and generics). In recent years, IV ketamine has been increasingly used (off-label) for treatment of TRD.

With the 2004 Olympics only weeks away, performance-enhancing drugs will once again be receiving a great deal of attention. The US Anti-Doping Agency has published a list of drugs banned in Olympic sports (www.usantidoping.org) that includes, at least for some sports, all but 2 of the drugs reviewed here.

The FDA has approved Aptensio XR (Rhodes), an extended-release formulation of methylphenidate hydrochloride, for treatment of attention-deficit/hyperactivity disorder (ADHD). The Aptensio XR capsules contain multilayer beads designed to provide both a rapid onset and a long duration of action. This formulation of methylphenidate has been available in Canada as Biphentin since 2006.

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.

Nabilone, an oral synthetic cannabinoid similar to delta-9-tetrahydrocannabinol (THC), the active ingredient in marijuana, has recently been reintroduced to the US market (Cesamet - Valeant) after a 17-year absence. The previous manufacturer discontinued marketing of the drug for commercial reasons. Nabilone is classified as a Schedule II controlled substance.

Paliperidone (Invega - Janssen) has been approved by the FDA in an extended-release formulation for treatment of schizophrenia. It is the primary active metabolite of the second-generation antipsychotic risperidone (Risperdal - Janssen), which is scheduled to lose its patent exclusivity in December 2007.

The FDA has approved Jornay PM (Ironshore), a capsule formulation of methylphenidate with a delayed-release outer layer and an extended-release inner layer, for once-nightly treatment of attention-deficit hyperactivity disorder (ADHD) in patients >6 years old. Jornay PM is the first methylphenidate product to become available in the US that is taken in the evening; other long-acting methylphenidate formulations are taken in the morning. It is being marketed specifically for patients who have disruptive ADHD symptoms in the morning.

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 lumateperone (Caplyta — Intracellular Therapies), an oral second-generation antipsychotic, for once-daily treatment of schizophrenia in adults. It is the 13th second-generation antipsychotic drug to be approved by the FDA for this indication.

View the Expanded Table: Some Oral Drugs for Chronic Insomnia