IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI) shares were flat at $2.50 on Wednesday and unchanged in after-hours trading. Share prices have been trading in a 52-week range of $1.58 to $3.35. The company has a market cap of $78.27 million at 30.57 million shares outstanding.
In a press release, IntelliPharmaCeutics Intl Inc shared that 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 for Rexista abuse-deterrent oxycodone hydrochloride extended release tablets should not be approved at this time.
In addition, the committee also voted 19 to 4 that IntelliPharmaCeutics Intl Inc has not demonstrated that Rexista has properties that can be expected to deter abuse by the intravenous route of administration. They did express 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.
“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,” said CEO of IntelliPharmaCeutics Intl Inc Dr. Isa Odidi.
IntelliPharmaCeutics Intl Inc is a Canada-based pharmaceutical company engaged in the research, development and manufacture of controlled-release and targeted-release oral solid dosage drugs.
Its Hypermatrix technology is a multidimensional controlled-release drug delivery platform that is applied to the development of a range of existing and new pharmaceuticals. Based on this technology platform, it has developed various drug delivery systems and a pipeline of products, and product candidates in various stages of development, in therapeutic areas that include neurology and cardiovascular. I
ts pipeline of products includes Rexista Oxycodone, Regabatin XR, Generic Focalin XR, Generic Effexor XR, Generic Protonix, Generic Glucophage XR, Generic Seroquel XR, Generic Lamictal XR, Generic Keppra XR, Generic Pristiq and Generic Ranexa. Its generic product candidates also include Trazodone hydrochloride extended-release tablets and Carvedilol phosphate extended-release capsules.