Traditional Drug Pipeline Update: August 2022

This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

See separate article for pipeline information on specialty drugs.

New Drug Information

• Zoryve^®(roflumilast) cream 0.3%: The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ Zoryve cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. Zoryve is the first topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis. Zoryve was approved based on two Phase 3 clinical trials that demonstrated Zoryve achieved investigator global assessment (IGA) success at week eight compared to vehicle 42% in DERMIS-1 and 37% in DERMIS-2 with Zoryve compared to 6% in DERMIS-1 and 7% in DERMIS-2 with vehicle.¹ Zoryve has launched with an average wholesale price (AWP) of $990 per tube (60 gram).
• Kyzatrex^® (testosterone undecanoate): Marius Pharmaceuticals’ Kyzatrex has been approved as an oral testosterone replacement therapy (TRT) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The approval was based on an open-label, Phase 3 study that evaluated the efficacy and safety of Kyzatrex. Results demonstrated that 88% of patients treated with Kyzatrex achieved a 24-hour mean plasma total testosterone concentration within the normal range of 222-800ng/dL on the final pharmacokinetic (PK) visit at day 90.² Kyzatrex is a Schedule III controlled substance and available as 100mg, 150mg, or 200mg of testosterone undecanoate capsules in 90-count bottles. It is not substitutable with other oral testosterone undecanoate products. Kyzatrex launch and price are pending.
• Auvelity^® (dextromethorphan and bupropion): The FDA has approved Axsome Therapeutics’ Auvelity extended-release tablets as a rapid-acting treatment of major depressive disorder (MDD) in adults. Auvelity was approved via the 505(b)2 pathway using dextromethorphan and bupropion as its reference products. Axsome anticipates Auvelity to be commercially available in the U.S. in the fourth quarter of 2022 with pricing to follow.³

Generic Drug Information

• None

+Specialty medication

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References

1. https://www.globenewswire.com/news-release/2022/07/29/2488966/0/en/FDA-Approves-Arcutis-ZORYVE-Roflumilast-Cream-0-3-For-the-Treatment-of-Plaque-Psoriasis-in-Individuals-Age-12-and-Older.html
2. https://www.empr.com/home/news/fda-approves-oral-testosterone-replacement-therapy-kyzatrex/
3. https://www.formularywatch.com/view/fda-approves-rapid-acting-auvelity-for-major-depression