Fabre-Kramer Pharmaceuticals, Inc., Houston, TX and Mission Pharmacal Company, San Antonio, TX have signed agreements providing for Mission to 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 Food and Drug Administration (FDA) for review and approval. The two companies also expect to enter into an agreement for Mission to manufacture and package the commercial supplies of Travivo once approved.
Mission will produce over 11 million Travivo tablets in 4 dosage strengths under current Good Manufacturing Practice (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.
Fabre-Kramer is executing on its program to complete the update of Travivo’s NDA agreed with the FDA in 2017. 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.
Fabre-Kramer is targeting a late 2018 submission of the Travivo NDA amendment, which will have a six month review period under PDUFA. Travivo represents a new class of antidepressant that effectively treats major depression via a novel, highly targeted mechanism of action (MoA).
Travivo acts as a specific agonist at the 5HT1a receptor. It is not a reuptake inhibitor and has no material norepinephrine or dopamine activity. This single receptor MoA is unique among antidepressants and results in significant benefits to patients relative to all other pharmacologic therapies.
Although numerous treatment options exist for adults with MDD, virtually all rely on neurotransmitter reuptake inhibition as the primary MoA.These drugs such as SSRIs and SNRIs are not always optimal since they are often associated with side effects including sexual dysfunction that limit their use.
Travivo has been shown to effectively treat the disorder without causing sexual dysfunction and with fewer other side effects than other antidepressants.
Mission Pharmacal’s pharmaceutical manufacturing facilities feature 300,000 square feet of product and warehousing space. Mission produces gels, liquids, creams, and semi-solids, along with more than 1.5 billion tablets a year.
(Source: Fabre-Kramer Pharmaceuticals, Inc.)
Filed Under: Drug Discovery
