IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) shares are sinking nearly 40% pre-market on robust volume in response to a negative advisory committee vote for the company’s abuse-deterrent drug (Rexista).
The Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted 22 to 1 in finding that the Company’s New Drug Application (“NDA”) for Rexista abuse-deterrent oxycodone hydrochloride extended release tablets should not be approved at this time. The committees also voted 19 to 4 that the Company has not demonstrated that Rexista has properties that can be expected to deter abuse by the intravenous route of administration and 23 to 0 that there are not sufficient data for Rexista to support inclusion of language regarding abuse-deterrent properties in the product label for the intravenous route of administration.
The committees expressed a desire to review the additional safety and efficacy data for Rexista that may be obtained from human abuse potential studies for the oral and intranasal routes of administration. Accordingly, the Company intends to conduct Category 3 abuse potential studies to provide the data the Company believes necessary to support abuse-deterrent properties of Rexista for the oral and intranasal routes, which are required for abuse-deterrent labeling claims for such routes. The Company has an FDA approved protocol for a human abuse potential study for the intranasal route of abuse, which it plans on commencing in the coming weeks.
Rexista is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The FDA is not bound by the advisory committees’ recommendation, but will consider their guidance as it continues its review of Rexista. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of September 25, 2017 for completion of its review of our Rexista NDA candidate.
The CEO of Intellipharmaceutics, Dr. Isa Odidi, said, “While we are disappointed with the Committees’ overall vote, we will endeavor to remedy the concerns raised by completing the necessary human abuse potential studies in relation to the intranasal and oral routes of abuse. We will continue to work with the FDA in progressing this file over the next few weeks as we approach the September 25, 2017 PDUFA date.”
There can be no assurance that we will not be required to conduct further studies for Rexista, that the FDA will approve any of the Company’s requested abuse-deterrent label claims or that the FDA will ultimately approve the NDA for the sale of Rexista in the U.S. market, or that it will ever be successfully commercialized.
On the ratings front, Intellipharmaceutics has been the subject of a number of recent research reports. In a report issued on July 25, Maxim analyst Jason Kolbert reiterated a Buy rating on IPCI, with a price target of $6.00, which represents a potential upside of 141% from where the stock is currently trading. Separately, on April 27, Aegis’ Difei Yang reiterated a Hold rating on the stock and has a price target of $2.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Difei Yang have a yearly average loss of 12.3% and a return of 9.9% respectively. Kolbert has a success rate of 31% and is ranked #4089 out of 4160 analysts, while Yang has a success rate of 51% and is ranked #343.
Intellipharmaceutics International, Inc. is a pharmaceutical company, which engages in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. Its patented Hypermatrix technology is a multidimensional controlled-release drug delivery platform that can be applied to the development of existing and new pharmaceuticals in the areas of neurology, cardiovascular, gastrointestinal tract, diabetes and pain.