New User:

Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 26, 2014
10:25 EDTIPCI, IPCI, IPCIIntellipharmaceutics to host special shareholder meeting
Special shareholder meeting to be held in Canada on March 27 at 10:30 am.
News For IPCI From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
May 21, 2015
11:47 EDTIPCIIntellipharmaceutics path for Rexista significantly shorter, says Brean Capital
Subscribe for More Information
08:14 EDTIPCIIntellipharmaceutics intends to accelerate Rexista Oxycodone XR program
Intellipharmaceutics announced that the FDA provided the company with notification regarding its Investigational New Drug Application, or IND, submission for Rexista Oxycodone XR extended release tablets. The notification from the FDA stated that the Company will not be required to conduct Phase III studies if bioequivalence to Oxycontin is demonstrated. The company had earlier announced, on March 30, that it had submitted an IND to the FDA for Rexista Oxycodone XR in anticipation of the commencement of Phase III clinical trials. At the same time the Company had also announced that topline data results of three definitive Phase I pharmacokinetic clinical trials all met the bioequivalence criteria when compared to the existing branded drug Oxycontin. The company believes, in light of these prior results, that it will not be required to conduct Phase III studies, although no assurance to that effect can be given. The company believes the FDA notification is significant as it provides a basis for an accelerated development plan for its Rexista Oxycodone XR product candidate, without the need for more costly and time-consuming Phase III studies. The company intends to file a New Drug Application, or NDA, for Rexista Oxycodone XR extended release tablets with the FDA within the next 6 to 12 months, although no assurance to this effect can be given. Further, there can be no assurance that the FDA will ultimately approve the NDA for sale of Rexista Oxycodone XR in the U.S. market, or that it will ever be successfully commercialized.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the disclaimer & terms of use