Tetra Bio-Pharma gets AdVersa meetings with FDA
Tetra Bio-Pharma (TSXV:TBP;OTCQB:TBPMF) received two granting letters from the FDA for Type B and C meetings to discuss requirements for obtaining marketing approval under the 505(b)(2) regulatory pathway for its dronabinol AdVersa mucoadhesive product, PPP002.
Tetra and IntelGenx (TSXV:IGX; OTCQX:IGXT) aredeveloping PPP002 in the U.S. under the accelerated 505(b)(2) pathway for chemotherapy-induced nausea and vomiting and anorexia and weight loss in people with AIDS, the same indications that have already been approved for Marinol.
Camargo, a specialty contract research organization, is guiding the regulatory submissions to the FDA. Tetra also is developing PPP002 in Canada as an adjunct therapy for opioid reduction in patients with chronic pain.
Based on the expected improved safety profile of delayed release dronabinol, Tetra expects that the AdVersa product can gain significant market share within three years of launch in the U.S.
“Confirmation of these two meetings with FDA marks an important milestone in gaining accelerated marketing approval in the USA for PPP002,” Dr. Guy Chamberland, interim CEO and CSO of Tetra, said in a statement. Tetra will use the information provided by the FDA in these meetings to finalize preparation of the NDA file, he added.
In addition, Tetra and IntelGenx are working together to finalize clinical trial applications (CTAs) for upcoming comparative pharmacokinetic and opioid sparing trials to support development for the 505(b)(2) and opioid sparing indications, respectively. Tetra expects to file these CTAs with Health Canada in the third quarter of 2018.