Vitality Biopharma Inc (OTCMKTS:VBIO) ended 2016 on a happy note by announcing approvals from two regulators for expanding development activities for novel cannabinoid pharmaceutical prodrugs. The company said that both the State of California Research Advisory Panel, as well as, the U.S. Drug Enforcement Agency (DEA) has given their nods for expanding activities of expansion at company’s facilities. Vitality Biopharma can now leverage its novel cannabinoid pharmaceutical prodrugs development activities in the factories.
Ensured adequate on-site measures for diverting Schedule I controlled substances
The company said that it worked closely with DEA to make sure that proper measures were taken on site to prevent leisurely use of Schedule I controlled substances. The company is working on development of proprietary prodrugs of CBD and THC and Cannabinoid is a vital component in the process.
Vitality Biopharma said that U.S. Food & Drug Administration (FDA) reviewed and approved the use of Cannabinoid in proprietary prodrugs development after analysis. Meanwhile, the company said that it has also received research permits from California Research Advisory Panel (California Attorney General’s Office) so as to start off with the cannabinoid pharmaceutical development activities. These will be targeted towards seeking regulatory approval of its clinical trials.
California’s Legalization and Strict Norms
California has been among the first few states in the U.S. to legalize the use of cannabis for medical and recreational purposes and Pharma R&D. Despite legalization, both, FDA as well as DEA, has strict norms and policies in place to closely regulate the approvals.
The company says that its THC and CBD prodrugs are meant for providing relief to psychoactive side effects with the help of company’s prodrug technology.
Vitality Biopharma’s senior executive associated with the process, Dr. Brandon Zipp stated that the company’s research will now be scaled up and it will “aggressively pursue clinical testing of compounds.”