Pernix signs agreement with Osmotica Pharmaceutical to promote Khedezla tablets

The sales and marketing of Khedezla will be supported by Pernix’s team of approximately 90 sales professionals, promoting the product to high desvenlafaxine prescribing physicians.

The new drug application (NDA) for Khedezla tablets was approved by the US Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act in July 2013. Khedezla is indicated for the treatment of major depressive disorder (MDD).

Pernix chairman and CEO Doug Drysdale noted the company is pleased to add Khedezla to the Pernix product portfolio.

"Khedezla provides Pernix with an opportunity to leverage its greatest asset – our team of 90 professional sales men and women and represents the first step in our transformation to specialist promotion. Khedezla has excellent promotional synergy with our sleep maintenance product, SILENOR. We believe that the ability to promote SILENOR and Khedezla side by side provides a valuable product offering to Pernix’s target physicians," Drysdale added.

The Khedezla NDA included comparative bioequivalence testing against Pfizer’s Pristiq (desvenlafaxine) extended-release tablets. According to IMS Health data, annual U.S. sales of Pristiq are approximately $614m.

Under terms of its agreement with Osmotica, Pernix will market, sell and distribute Khedezla in the US. Pernix and Osmotica will share profits from the sales of the product. The transaction was completed without the use of any proceeds from Pernix’s recently closed Senior Notes 2019 offering.