IntelliPharmaCeutics (IPCI) Rexista NDA Filing Expected, But 'Very Good News' - Maxim Group
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Maxim Group analyst Jason Kolbert reiterated a Buy rating and $6 price target on IntelliPharmaCeutics International (NASDAQ: IPCI) after the company announced the filing (NDA) for Rexista (abuse-deterrent oxycodone) extended release tablets (10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths). While this was highly expected we view this as very good news for the company.
- The submission also includes a comprehensive array of abuse-deterrent studies conducted to support abuse-deterrent label claims related to abuse of drug by oral, intra-nasal and intravenous pathways, having reference to the FDA's "Abuse-Deterrent Opioids — Evaluation and Labelling" guidance published in April 2015.
- The abuse-deterrent properties incorporated into Rexista are designed to make the product unlikable and discourage or make it more difficult to manipulate for the purpose of abuse or misuse via common routes of administration including: ingestion following chewing, licking or crushing; insufflation; inhalation; or injection.
- The Company previously announced the results of a food effect study which showed that Rexista can be administered with or without a meal (i.e., no food effect), providing another point of differentiation from currently marketed oral oxycodone extended release products.
- Conclusion. The NDA filing is positive news. The next step will be acceptance (60 days) for Rexista, followed by the PDUFA (6 months from acceptance) date, setting the stage for a partnership opportunity.
Shares of IntelliPharmaCeutics International closed at $3.00 yesterday.
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Related EntitiesMaxim Group, PDUFA
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