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Intellipharmaceutics Submits NDA for Pain Treatment Rexista


Intellipharmaceutics International Inc. IPCI announced that it has filed a new drug application (NDA) with the FDA for Rexista (abuse-deterrent oxycodone hydrochloride extended release tablets) in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.

The company is looking to get Rexista approved for the management of pain, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

We note that Rexista is a bioequivalent of Purdue Pharma’s OxyContin (oxycodone hydrochloride extended release).

Notably, this marks Intellipharmaceutics’ first regulatory submission in the U.S. Upon approval, Rexista could be the first abuse-deterrent oxycodone product that not only resists common forms of abuse but also provides a preventive tool that flags early signs of abuse.

The company has identified potential manufacturing partners and is currently evaluating various manufacturing options for Rexista in the U.S.

Meanwhile, in Oct 2016, Intellipharmaceutics entered into a license and commercial supply agreement with Mallinckrodt Public Limited Company MNK, granting the latter an exclusive license to market, sell and distribute generic Seroquel XR, Pristiq and Lamictal XR in the U.S., for which Intellipharmaceutics has filed abbreviated NDAs. While generic version of Seroquel XR has been tentatively approved by the FDA, generic versions of Pristiq and Lamictal are currently under review.

Intellipharmaceutics currently carries a Zacks Rank #3 (Hold).


Stocks to Consider

A couple of better-ranked stocks in the healthcare sector include Incyte Corporation INCY and Arbutus Biopharma Corporation ABUS. Arbutus sports a Zacks Rank #1 (Strong Buy), while Incyte carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Incyte’s earnings estimates increased from 23 cents to 64 cents for 2016 and from $1.46 to $1.68 for 2017 over the last 30 days. The company posted a positive average beat of 431.43% over the last four quarters.

Arbutus’ loss estimates narrowed from $2.15 to $1.74 for 2016 and from $1.96 to $1.51 for 2017 over the last 30 days. The company posted positive surprises thrice in the four trailing quarters with an average beat of 59.31%.

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