Intellipharmaceutics Up on Positive Rexista Oxycodone Data – Zacks.com

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 (more…)

Painkiller Remoxy (Oxycodone) May Still See An NDA Refiling By Mid-2015 (PTIE) – Seeking…

Summary

  • Pfizer announced it was returning the Remoxy rights to the initial filers of the NDA, Pain Therapeutics, the shares of which sank 53% on the news.
  • However, a search on ClinicalTrials.gov reveals that Pfizer has completed all the necessary Phase I bioequivalence trials required to address the FDA‘s last Complete Response Letter.
  • That may be enough to attract a new partner for the (more…)

Collegium Pharmaceutical Announces Successful Pre-NDA Meeting With FDA … – SmallCap…

family:arial,sans-serif”> family:arial,sans-serif”>
Collegium Pharmaceutical Announces Successful Pre-NDA Meeting With FDA
SmallCap Network
The purpose of the meeting was to discuss the non-clinical, clinical and Chemistry, Manufacturing and Controls (CMC) development of Oxycodone DETERx, and to agree on the submission requirements for the NDA submission under 505(b)(2) of the Federal …

and more »

Original post:
Collegium Pharmaceutical Announces Successful Pre-NDA Meeting With FDA … – SmallCap…