Fabre-Kramer Pharmaceuticals, Inc. and Mission Pharmacal Co. have signed agreements under which Mission will complete the technology transfer to develop and manufacture the registration batches of Fabre-Kramer’s novel antidepressant, Travivo (gepirone HCl) Extended Release Tablets. Data from these batches will be used to support the submission of the NDA Amendment for Travivo to the FDA for review and approval. The companies also expect to enter an agreement for Mission to manufacture and package the commercial supplies of Travivo once approved.

Mission will produce more than 11 million Travivo tablets in four dosage strengths under cGMP as part of the registrational program. Analytical data from each batch produced will be collected by Mission and will be part of the NDA amendment submission later in 2018. These tablets will also be suitable for future commercial sale upon FDA approval.

In addition to the manufacture, bioequivalency and stability testing of the registration batches, work is ongoing on several small in-vivo and in-vitro studies to provide pharmacokinetic data to include in proposed labeling.

Travivo is a new class of antidepressant that treats major depression via a highly targeted mechanism of action (MoA) that acts as a specific agonist at the 5HT1a receptor. Travivo has been shown to effectively treat the disorder without causing sexual dysfunction and with fewer other side effects than other antidepressants.

Stephen Kramer, MD, chief executive officer of Fabre-Kramer, said, “We are delighted to be partnering with Mission Pharmacal for our Travivo program. They were chosen after an extensive and careful review of several highly qualified potential manufacturers. Mission has the perfect combination of facilities, equipment, experience, and capabilities to ensure the registrational program goes smoothly and expeditiously, as well as the capacity to manufacture Travivo tablets in the 100 million+ annual commercial volumes we anticipate once approved.”

“Fabre-Kramer’s Travivo program is an exciting new partnering relationship for Mission. Travivo has the potential to garner a significant share of the US branded antidepressant market and thus represent a large-scale ongoing customer for Mission’s range of services. We look forward to leveraging our extensive related expertise to ramp up the registrational batch manufacturing and packaging smoothly, to working with Fabre-Kramer to satisfy all of FDA’s CMC requirements for Travivo’s NDA amendment and to transitioning to an important commercial supply contract once Travivo is approved,” said Neill Walsdorf, Jr., president of Mission Pharmacal.