December 2025 Product Updates

Rx Products

Lumateperone (Caplyta)

From: Johnson & Johnson

The FDA approved lumateperone (Caplyta; Johnson & Johnson) as an adjunct therapy with antidepressants for the treatment of adults with major depressive disorder. Lumateperone is an oral, once-daily atypical antipsychotic drug that was previously approved as a monotherapy for adults with schizophrenia and depressive episodes associated with bipolar I or II disorder. Results from 2 phase 3 global, double-blind, placebo-controlled trials highlighted lumateperone’s efficacy and safety for this indication. Each study met its key primary and secondary end points, demonstrating statistically significant and clinically meaningful improvements in depression symptoms compared with an oral antidepressant plus placebo. The investigators determined that lumateperone 42 mg as an adjunct treatment significantly improved depression symptoms and disease severity while being well tolerated in patients.

For more information: caplyta.com

Elinzanetant (Lynkuet)

From: Bayer

FDA officials approved elinzanetant (Lynkuet; Bayer), the first dual NK1 and NK3 receptor antagonist for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Elinzanetant acts within the brain’s thermoregulatory center to restore temperature balance disrupted during menopause. The approval was supported by results from the phase 3 OASIS-1 (NCT05042362), OASIS-2 (NCT05099159), and OASIS-3 (NCT05030584) clinical trials, which together demonstrated significant and sustained efficacy in reducing both the frequency and severity of VMS as well as improving sleep and overall menopause-related quality of life.

For more information: lynkuet-us.com

OTC Product

URO Metabolism + Probiotic

From: O Positiv Health

URO Metabolism + Probiotic is a new daily supplement formulated to help women feel more energized, curb cravings, reduce bloating, and support healthy weight management. The product combines clinically informed metabolic support with a targeted probiotic blend designed to optimize both gut and metabolic health. With a multifunctional ingredient profile, URO Metabolism + Probiotic features chromium picolinate to aid appetite regulation and maintain healthy blood glucose levels, along with vitamin B₁₂ to help convert food into energy and sustain overall energy metabolism. A blend of caffeine and green coffee extract provides an added boost by supporting healthy metabolism, enhancing focus, and contributing to weight management efforts. Central to the formula is a targeted probiotic blend including Bifidobacterium lactis IDCC 4301, Akkermansia, and Lactobacillus gasseri, selected for their roles in promoting digestive comfort, reducing bloating, supporting a healthy gut lining, and assisting with weight management goals.

For more information: opositiv.com

Generic Product

Risperidone Extended-Release Injectable Suspension

Compare to: Risperdal Consta Long-Acting Injection

From: Lupin

Lupin has launched risperidone for extended-release injectable suspension in 25-mg, 37.5-mg, and 50-mg single-dose vials, entering the US market with 180-day competitive generic therapy exclusivity. The product marks the company’s first commercial use of PrecisionSphere, the long-acting injectable technology developed by its Nanomi subsidiary. The formulation is approved for the treatment of adults with schizophrenia as well as for maintenance therapy in adults with bipolar I disorder, either alone or alongside lithium or valproate.

For more information: lupin.com