Clobazam (Onfi – Lundbeck), an oral benzodiazepine, has been approved by the FDA for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ≥2 years old. It has been available in Canada (Frisium) and other countries for years for treatment of anxiety and many types of epilepsy.

Augmentation with a second-generation (atypical) antipsychotic is a treatment option for patients with major depressive disorder (MDD) whose symptoms persist following antidepressant monotherapy. Aripiprazole (Abilify), olanzapine in a fixed-dose combination with fluoxetine (Symbyax), and extended-release quetiapine (Seroquel XR) have been approved by the FDA for such use.

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.

Duloxetine hydrochloride (Cymbalta - Lilly), a selective serotonin and norepinephrine reuptake inhibitor (SNRI) available for treatment of depression, has also been approved by the FDA for treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN). Duloxetine is one of two drugs approved specifically for management of neuropathic pain due to diabetes; the other, pregabalin (Lyrica - Pfizer), will be marketed soon and will be reviewed in the next issue of The Medical Letter.

The FDA has approved a second extended-release (ER) formulation of the oral opioid agonist hydrocodone (Hysingla ER – Purdue) for management of pain severe enough to require continuous long-term therapy and for which alternative treatment options are inadequate. Hysingla ER tablets have abuse-deterrent properties to discourage their misuse.

The FDA has approved an extended-release oral suspension formulation of amphetamine (Adzenys ER – Neos) for treatment of attention deficit hyperactivity disorder (ADHD) in patients ≥6 years old. The same extended-release amphetamine product is available as an orally disintegrating tablet and is marketed as Adzenys XR-ODT. Another extended-release oral suspension formulation of amphetamine, Dyanavel XR, was approved earlier.

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 recently approved the monoamine oxidase inhibitor (MAOI) selegiline in a transdermal (patch) formulation (Emsam - Bristol-Myers Squibb/Somerset) for treatment of major depressive disorder. Selegiline is also available in an oral formulation (Eldepryl, and others) for treatment of Parkinson's disease.

The FDA has approved lofexidine (Lucemyra – US WorldMeds/Salix), a centrally acting alpha₂ receptor agonist, to manage withdrawal symptoms in adults abruptly stopping opioid use. Available in the UK since 1992, lofexidine is the first nonopioid to be approved in the US for management of opioid withdrawal symptoms. Clonidine (Catapres, and generics), another central alpha₂ receptor agonist, has been used off-label for this indication for many years.

Eszopiclone (Lunesta - Sepracor), a benzodiazepine-like drug, has been approved by the FDA for oral treatment of insomnia. It is the S-isomer of zopiclone (Imovane, and others in Canada), which has been available in other countries for almost 20 years. Unlike similar drugs such as zolpidem (Ambien) or zaleplon (Sonata), Lunesta is not being restricted in its labeling to short-term use. Like other hypnotics, eszopiclone is a schedule IV drug.