Tetra Bio-Pharma Provides Additional Information on QIXLEEF Following Letter of Advice & Type B Meeting with USA FDA
QIXLEEF global market is expanded to include noncancer pain indications.
Scientific approach to quality control of QIXLEEF validated by FDA.
OTTAWA, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V: TBP) (OTCQB: TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to
provide additional information on the drug development program for QIXLEEF following the previously announced Letter of Advice and Type B meeting with the US Food and Drug Administration
The clinical development program of QIXLEEF in the USA begins with the PLENITUDE clinical trial. This FDA authorized clinical trial assesses the clinical impact of QIXLEEF in advanced cancer
patients with uncontrolled pain. A successful PLENITUDE clinical program, allows Tetra to commercialize the world’s first dried flower botanical cannabinoid drug product for the treatment of
pain in patients with an advanced refractory cancer.
The FDA validated Tetra’s nonclinical program proposed to support clinical trials in non-cancer pain indications and the New Drug Application. This guidance from FDA is critical to the success of the clinical trials and the timing to commercialization because of the costs implicated with the performance of a full nonclinical program. The FDA confirmed areas where Tetra could obtain a waiver for some of the nonclinical safety requirements based on the target patient population. "Confirmation of the waivers was critical because it confirms Tetra’s understanding of the regulatory requirements. The waivers represent a short-term savings of over 5 million dollars for the first marketing application of QIXLEEF as well as further potential savings,” stated Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra.
Tetra will expand the program to target patients with non-cancer pain indications, under the guidance of the FDA as the PLENTITUDE clinical program advances. The Company would then seek approval for a non-cancer pain indication, such as a second-line or third- line therapy for a condition of uncontrolled pain. Uncontrolled pain refers to a state where the standard of care medications has not achieved adequate control of the pain. A second- or third-line therapy is only initiated once a patient has received the first-line of therapy (e.g., ibuprofen, duloxetine, pregabalin) but has not obtained enough relief.