March 2023 Rx Product News

Cariprazine (Vraylar)

From: AbbVie; Gedeon Richter Plc

The FDA has approved cariprazine (Vraylar) from AbbVie and Gedeon Richter Plc as an adjunctive therapy to antidepressants for individuals with major depressive disorder. It is intended to be administered at a starting dose of 1.5 mg once daily and can be increased to 3 mg once daily on day 15, depending on clinical response and tolerability. The maximum recommended dose is 3 mg. Additionally, cariprazine is also approved to treat individuals with acute manic, depressive, and mixed episodes associated with bipolar I disorder and schizophrenia. The most common adverse events include akathisia, insomnia, and nausea.

For More Information:

vraylar.com

Zavegepant Nasal Spray

From: Biohaven Ltd

Treatment with the zavegepant nasal spray (Biohaven Ltd) has demonstrated positive findings in a phase 2/3 trial (NCT03872453) for the acute treatment of migraines. Zavegepant nasal spray is a calcitonin gene-related peptide receptor antagonist. The study results showed that the 10- and 20-mg doses were more effective than the placebo for pain relief at 2 hours after dose administration by 22.5% and 23.1%, respectively. Additionally, the 10- and 20-mg doses fared better than the placebo in relief from the most bothersome symptoms at 2 hours after administration at 41.9% and 42.5%, respectively.

For More Information:

biohaven.com

Lenacapavir (Sunlenca)

From: Gilead Sciences, Inc

Lenacapavir (Sunlenca) from Gilead Sciences, Inc, is a first-in-class inhibitor approved by the FDA for the treatment of individuals with HIV-1 whose infection cannot be treated with other available treatments because of intolerance, resistance, or safety concerns. The drug works by blocking the HIV-1 virus’ capsid, interfering with multiple parts of the viral life cycle. After the starting dose, the injection is administered once every 6 months in combination with other antiretrovirals. The most frequently reported adverse events included nausea and injection site reactions including pain, redness, and swelling.

For More Information:

gilead.com

Zuranolone

From: Biogen Inc and Sage Therapeutics, Inc

A rolling submission to the FDA of a new drug application (NDA) for zuranolone from Biogen Inc and Sage Therapeutics, Inc, has been completed. The NDA is for the treatment of major depressive disorder and postpartum depression. Zuranolone is an investigational drug being evaluated as a 14-day, once-daily, rapid acting oral therapy. The submission includes data from the LANDSCAPE and NEST clinical development programs. The drug has shown a rapid and sustained improvement of depression symptoms and is generally well tolerated, with a consistent safety profile.

For More Information:

sagerx.com