Tetra Biopharma (TBP.V) has been busy conducting clinical development programs of two potential products, the first being Quixleef and the second Plenitude. Both involve dealing with uncontrolled pain in patients dealing with medicine resistant cancers.
For the record, uncontrolled pain means pain that’s too much for standard medication, where a second or a third line therapy has been implemented once the standard course of drugs like ibuprofen, duloxetine or pregabalin, hasn’t brought sufficient relief.
In order to perform these tests, though, they needed to get a waiver from the American Food and Drug Administration 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,” according to Dr. Guy Chamberland, CEO and chief regulatory officer of Tetra.
A little FDA 101
For those whose PhDs are in the mail, the difference between a clinical and nonclinical trial is that typically clinical trials are done on humans, and nonclinicals aren’t. In this case, it would mean the FDA had to look into the safety factors involving nonhuman test subjects to ensure that results wouldn’t cause undue harm, and would be typical.
The FDA has established procedures to ensure that new treatments are safe and effective before they can go to market.
The stages of the development process are:
- Discovery and development – research begins in the laboratory, where insights into the way PD develops and progresses allow researchers to design or find products that may impact the disease
- Preclinical (or non-clinical) research – testing of a new drug or therapy to determine its safety and effectiveness prior to testing in humans
- Clinical research – testing the new treatment in humans
- FDA review – analysis of all the data from research trials by the FDA review team
- Post-market safety monitoring – additional studies done after the drug is approved and is available in the market to gather information on long-term
The clinical development program of Quixleef in the USA begins with the Plenitude clinical trial. The trial is being done to assess the clinical impact of Qixleef in advanced cancer patients with uncontrolled pain. A successful Plenitude program will let Tetra get started on commercializing the world’s first dried flower botanical drug product for pain management in patients with an advanced cancer that’s been resistant to treatments thus far.
The FDA is overseeing the trials, ensuring that the Tetra’s raw flower and drug product requirements are uniform in both their nonclinical and clinical trials. Tetra needs to demonstrate to the FDA that Qixleef batches used in both trials will be comparable to those used commercially, as well as those that were used at each stage in the drug’s development program.
FDA validation of the botanical raw material and quality control is essential to ensure the acceptability of the data packages that will be used for the marketing application, as well as to ensure successful penetration into the global markets.
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,” said Chamberland.
The FDA validated Tetra’s nonclinical program and gave them the nod to move forward with clinical human trials in non-cancer pain indications and the new drug application. This guidance is critical to the success of Tetra’s clinical trials and the timing to commercialization because of the costs associated with the performance of a full nonclinical program.
The expansion of the indications will give Qixleef the impetus it needs to compete in the incredibly competitive $44.3 billion market compared to the previous $2 billion market. The larger market includes all first line therapies and self care options. Comparatively, Duloxetine and pregabalin, were both selling at the $9 billion at peak.
—Joseph Morton