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 (FDA).
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.
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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.
The FDA reviewed and provided scientific validation of Tetra’s proposed approach to ensuring the quality of the botanical raw material and drug product specifications and how Tetra will ensure the comparability of the non-medicinal ingredients (i.e., volatile organic compounds) from lot-to-lot across the nonclinical and clinical programs. Tetra must demonstrate to the FDA that the QIXLEEF™ batches used in clinical trials will be comparable to those of the commercial lots as well as those that were used at every stage of the drug development program.
The FDA’s validation of the botanical raw material specifications and quality control was essential to ensure the acceptability of the data packages that would be used for the marketing application as well as ensuring a successful global market penetration. “There is biological variability associated with the use of any botanical raw material. Obtaining the FDA’s validation on the scientific approach used by Tetra was a significant step forward for QIXLEEF™. We are now in an excellent position to bring this new drug to the market,” stated Dr. Guy Chamberland.
The expansion of the indications will allow QIXLEEF™ to compete in a very competitive $44.3Bn market size1 compared to the previous $2Bn market. The $44.3Bn market includes all first line therapies and self care options. Duloxetine and pregabalin, for example, at peak, were both selling $9Bn globally2.
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