Tetra Bio-Pharma (TSXV:TBP; OTCQB:TBPMF) is partnering with a major manufacturer of controlled active pharmaceutical ingredients in the U.S. to manufacture Dronabinol XL AdVersa as part of the company’s plans to submit a 505(b)(2) NDA for the treatment of chemotherapy-induced nausea and vomiting and anorexia associated with weight loss in patients with AIDS.
In March 2017, Tetra licensed the Dronabinol XL AdVersa technology from IntelGenx (OTCQX:IGXT; TSXV:IGX) and entered into a co-development agreement to bring the controlled release formulation of Dronabinol to market.
The submission of an NDA under 505(b)(2) to the FDA requires demonstration that the new controlled release formulation provides similar systemic exposure to the approved drug, dronabinol.
In a statement, the company said data generated by IntelGenx demonstrated that the new formulation increases bioavailability of THC and the new route of administration results in a lower level of the metabolite, 11-hydroxy THC. The implications are that a lower dose of THC will be required.
The Dronabinol XL AdVersa formulation is absorbed by the buccal mucosa, limiting exposure to the gastrointestinal tract, which is expected to reduce side effects of current dronabinol capsules.
In 2018, Tetra plans to perform a comparative pharmacokinetic study of Dronabinol XL AdVersa versus the listed drug. The study, along with the manufacturing file, would be part of Tetra's planned 505(b)(2) application.
The company expects to complete the analysis of the trial data and announce results in the fourth quarter of 2018, followed by a potential NDA submission in 2019. It also will request classification under Schedule III of the Schedules of Controlled Substances.
Dr. Guy Chamberland, CSO of Tetra, said that in parallel with the preparation of the NDA file, Tetra and IntelGenx plan to continue development of PPP002 (Dronabinol XL AdVersa) as an adjunct therapy for opioid sparing in chronic cancer pain. PPP002/Dronabinol XL AdVersa is a sustained release formula of THC in the form of a buccally absorbed tablet.