Intellipharmaceutics International Inc. (IPCI)

[JJAAMMAANN]

The More I read, the more I like this Company! Should really start to take off by July!

Intellipharmaceutics Up on Positive Rexista Oxycodone Data

by Zacks Equity Research Published on January 15, 2016 |

Shares of Intellipharmaceutics International Inc. (IPCI - Snapshot Report) surged significantly after the company announced that the bioequivalence trials on Rexista Oxycodone XR extended release tablets have demonstrated bioequivalence to privately held Purdue Pharma’s Oxycontin extended release tablets.



We note that Rexista Oxycodone XR is Intellipharmaceutics’ non-generic extended release formulation for the management of moderate-to-severe pain when an analgesic is required constantly.

Intellipharmaceutics conducted the study as per the design recommended by the FDA and compared the lowest and highest strengths of the exhibit batches of Rexista Oxycodone XR to the same strengths of the reference drug, Oxycontin.

Patients enrolled in the trial were dosed with or without fasting.

In 2015, Intellipharmaceutics announced top-line results from three definitive phase I pharmacokinetic clinical trials on Rexista (single-dose fasting, single-dose steady-state fasting, and single-dose fed), which showed that the drug met all FDA bioequivalence criteria when compared to Oxycontin.

In May 2015, the FDA notified the company upon its Investigational New Drug application submission for Rexista Oxycodone XR that Intellipharmaceutics will not be required to conduct phase III studies if bioequivalence to Oxycontin was demonstrated.

Consequently, the company now plans to complete the regulatory filing requirements and file a New Drug Application (NDA) for Rexista Oxycodone XR with the FDA within the next six months. The NDA will be filed in accordance with the NDA 505(b)(2) regulatory pathway.

Our Take

Results of the trial bode well for Intellipharmaceutics. Since the company is not required to conduct any phase III efficacy trial given positive results from the bioequivalence trials, it will save a lot of time and cost to the company.

Successful development and commercialization of Rexista Oxycodone XR product will be a big boost to the company.



Moreover, the NDA for candidates filed under NDA 505(b)(2) pathway enjoy an exclusivity period upon approval, which, in turn, provides them greater commercial opportunity relative to the generic Abbreviated New Drug Applications (ANDA) pathway.

We remind investors that the FDA has given final approval to the company’s generic version of Focalin XR (dexmethylphenidate hydrochloride extended release in 15-mg and 30-mg strengths).
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