The US Food and Drug Administration has supported Tetra Bio Pharma Inc (OTCMKTS:TBPMF) with a favorable letter of advice to advance the development of QIXLEEF, which provides relief from uncontrolled pain for adults.
Shows commitment of US FDA
Chief Regulatory Officer and Chief Executive Officer of Tetra Bio, Dr. Guy Chamberland, said the company is excited to receive a favorable letter from advice (LOA) from the US FDA. It shows the commitment of the US FDA to give the nod for this botanical drug to cure chronic pain on achieving positive quality and human clinical data.
The LOA from the US FDA encourages Tetra Bio to advance the development of QIXLEEF to treat chronic pain in patients who have cancer. CEO also said LOA confirms the previous commitment of the FDA to develop and commercialize QIXLEEF to cure non-cancer pain and cancer pain as a second or third line of therapy.
FDA gives in-depth guidance to Tetra Bio
The US FDA gave in-depth guidance to Tetra Bio on January 26, 2017, on advancing QIXLEEF development. Now the recent LOA provides new guidance to Tetra Bio considering the safety and clinical progress of QIXLEEF concerning quality and effectiveness and issues the guidelines for approval to market the drug for non-pain and cancer pain indications.
Commenting on the receipt of LOA from the US FDA, Dr. Guy said the collaboration with FDA is excellent and helps the company to develop prescription drugs complying with laid out requirements for pharmaceutical products.
The demand for pain management is $130 billion
The demand for pain management across the world is expected to reach $130 billion by 2023 from $60 billion in 2016. The pain management drug list comprises medications for chronic back pain, cancer pain, fibromyalgia, neuropathic pain, Migraine, Postoperative Pain, and Arthritic Pain. Dr. Guy said the company is confident of developing QIXLEEF for pains beyond cancer pain. It can be used as a third or second-line therapy to get relief from pain.
Health Canada grants two OTC DINs
Health Canada has granted two over the counter drug identification numbers for Tetra Bio. The company will market the new drugs under the banner TERPACAN by mid-2020. It will also introduce these new products in Europe and the US markets this year.
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