Momentum Public Relations
Press Release: October 11, 2018
Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), today announced it received the response letter for a Type C meeting with the United States Food and Drug Administration (FDA) for PPP002, its dronabinol AdVersa™ mucoadhesive product. The meeting was held to confirm that the proposed chemistry and manufacturing and non-clinical development plan for PPP002 for the 505(b)(2) is acceptable.
The FDA established that Tetra Bio-Pharma’s proposed bridging strategy fulfilled all the requirements of the 505(b)(2) regulatory pathway for the product PPP002. The FDA also provided feedback on the chemistry and manufacturing aspects of the drug development plan. The FDA further confirmed that the product control strategy, ensuring the identity, potency, purity and quality of the PPP002 buccal tablets was acceptable thereby determining that Tetra Bio-Pharma’s plan is on track for drug approval.
“We have now completed our meetings with the U.S. FDA and Tetra is well on its way to finalizing the development plan to bring PPP002 to market,” said Guy Chamberland, M.Sc., Ph.D., Interim Chief Executive Officer and CSO of Tetra Bio-Pharma. “With both the Type B and C meetings now behind us, we are able to move forward with executing the clinical program for PPP002 and subsequently submit the New Drug Application to commercialize PPP002.”
Tetra, along with its partner IntelGenx Corp, is developing this product in the United States under the accelerated 505(b)(2) pathway for the indication of chemotherapy-induced nausea and vomiting, and anorexia and weight loss in people with AIDS. These are the same indications that have already been approved for Marinol®. The 505(b)(2) speciality Contract Research Organization, Camargo, is guiding the regulatory submissions to the FDA. Tetra is also developing PPP002 in Canada as an adjunct therapy for opioid reduction in patients with chronic pain.
According to the International Agency for Research on Cancer, the global chemotherapy-induced nausea and vomiting (CINV) market will reach a valuation of US $1.88 billion by 2020, an increase from its 2013 valuation of US$1.28 billion. Based on the expected improved safety profile of delayed release dronabinol, Tetra expects that AdVersa™ can gain significant market share within three years of its launch in the USA.
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma