Phyto-pain pharma declared the submission of orphan drug application for Delta-9-tetrahydrocannibinol and Cannabidiol

Release Date: 23-Nov-2016

PhytoPain Pharma Inc., a subsidiary of GrowPros Cannabis Ventures Inc. stated h submission of two applications for orphan drug designation for Delta-9-tetrahydrocannibinol and Cannabidiol to the US Food and Drugs Administration (FDA), organization responsible for orphan drug development for the treatment of patients with Complex Regional Pain Syndrome Type 1 (CRPS1) and patients with Central Post Stroke Pain (CPSP). The FDA’s decision is still pending, if approved, the company is looking forward for several opportunities and benefits such as most notably tax credits on clinical research reduction of the waiting period and reduced registration fees. It also provides PPP with a 7-year period of market exclusivity in the U.S.


The FDA’s Orphan Drug program offers orphan status to drugs and biologics that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S. The designation provides sponsors with development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design and an exemption from FDA user fees.


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