NEW YORK (TheStreet) -- Intellipharmaceutics (IPCI) shares are up 9.3% to $3.38 in afternoon trading on Tuesday after the pharmaceutical company said that the FDA granted its abuse deterrent oxcodone drug Rexista fast track status.
Fast track designation mandates the FDA expedite the review process for drugs that treat serious illnesses and demonstrate the potential to address unmet medical needs.
Oxycontin is a popular narcotic pain reliever used to alleviate moderate to severe pain in patients and is an extremely addictive opioid. An abuse-deterent version of the drug would be an attractive alternative for people with prior drug abuse problems.
Last week the company announced plans to accelerate development of Rexista after receiving correspondence from the FDA saying that the company could skip phase III testing of the drug if it can prove bioequivalence to oxycontin.
"We are thrilled with the FDA's positive acknowledgement, which enables us to accelerate the development and commercialization of our abuse deterrent Rexista Oxycodone XR product candidate. The avoidance of a Phase III trial eliminates a significant financial hurdle. More importantly, it shortens the development timeline and potential time to market," said CEO and co-founder Dr. Isa Odidi.
The stock is moving on heavy volume trading today with 3.13 million shares changing hands today, well ahead of its three month daily average of 144,000 shares.
TheStreet Ratings team rates INTELLIPHARMACEUTICS INTL as a Sell with a ratings score of D. TheStreet Ratings Team has this to say about their recommendation: