Pernix Therapeutics Holdings, Inc. (NASDAQ GM: PTX) (“Pernix” or the “Company”), a specialty pharmaceutical company, today announced that it has signed an agreement with Osmotica Pharmaceuticals Corp (“Osmotica”) to market and sell KHEDEZLA™ (desvenlafaxine) Extended-Release (ER) Tablets, 50 mg and 100 mg. 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 U.S. 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).
“We are pleased to add KHEDEZLA to the Pernix product portfolio,” said Doug Drysdale, Chairman and CEO of Pernix. “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.”
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 $614 million. Under terms of its agreement with Osmotica, Pernix will market, sell and distribute KHEDEZLA in the United States. 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.
Important Information about KHEDEZLA ER TabletsA black box warning is associated with this product regarding increased risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants. All persons taking KHEDEZLA should be monitored for worsening and emergence of suicidal thoughts and behaviors. KHEDEZLA is not approved for use in pediatric patients. Refer to full prescribing information for complete boxed warning.