Aphios® Pharma LLC, headquartered in Woburn, MA, USA , is developing FDA-approved, cannabis-based drugs for treating highly unmet central and peripheral nervous system disorders of Opioid Addiction and Pain that are only partially and anecdotally addressed by medical marijuana.
Aphios® Pharma is dedicated to the delivery, development and commercialization of cannabis-based drugs for CNS and other debilitating disorders. We will manufacture and utilize pharmaceutical-grade pure natural cannabinoids in stable, bioavailable nanoformulations, following cGMP guidelines of the FDA. These cannabinoid nanoformulations will be used to establish clinical evidence for treating highly unmet CNS disorders such as opioid addiction and pain, epilepsy including childhood epilepsy and multiple sclerosis that are only partially and anecdotally addressed by medical marijuana.Apart from the recent FDA approval of Epidiolex (GW Pharma, London, England) for specific cases of childhood epilepsy, there is little rigorous clinical evidence of the efficacy of cannabinoids for significant CNS neurological disorders, and a lack of availability of pharmaceutical-grade cannabinoids to conduct rigorous clinical studies. These issues are compounded by a prohibitive DEA, NIH and FDA regulatory environment for developing FDA-approved, cannabis-based drugs. From a technical perspective, cannabinoids are very hydrophobic (poorly water soluble) making formulation difficult and bioavailability poor; also, cannabinoids are very oxygen sensitive and unstable, contributing to inconsistencies in therapeutic performance.
We plan to develop, in compliance with the Drug Enforcement Agency (DEA), FDA-approved cannabinoid therapeutics that target opioid addiction [APH-1501] and chemotherapy induced peripheral neuropathic pain (CIPNP) [APH-1502].