IntelliPharmaCeutics International Inc. (NASDAQ: IPCI)
Intellipharmaceutics (IPCI) stock is seeing quite a bit of movement on news that the FDA has accepted the company’s NDA filing for Rexista, its abuse deterrent opioid analgesic for the treatment of moderate to severe pain.
IPCI has been a focus stock for the Soulstring Nation, and this is the first of several milestones expected in the first half of 2017. While generally expected, this acceptance action by the FDA places IPCI in an enviable position to corner a significant share of the emerging abuse deterrent drugs market, a niche being aggressively endorsed by the FDA to control the widespread abuse of prescription medications.
IPCI Establishes PDUFA Date
The acceptance of the filing triggers a PDUFA date of September 25, 2017, at which time the FDA will make its final decision whether or not to approve Rexista. What is important to note for IPCI, though, is that the company had worked closely with the FDA in designing the application and had satisfied, in advance, concerns about “food effect” in relation to drug efficacy. This was the primary concern raised by the FDA prior to the filing.
IPCI clearly demonstrated that there was no “food effect”, which means that Rexista may be taken with or without the intake of food and will have no effect on the strength or efficacy of the drug. While nothing is ever a “sure thing” when it comes to the FDA, the likelihood for approval plays in favor for Rexista, and absolutely enhances the partnership and licensing opportunities for IPCI.
The CEO of Intellipharmaceutics, Dr. Isa Odidi, said,“The acceptance of our NDA for Rexista represents an important step towards the commercialization of a potentially best–in-class abuse-deterrent oxycodone hydrochloride extended release product. We look forward to working with the FDA during their review of our NDA submission.”
Pain Management Without Abuse
Rexista is an opioid compound indicated for the management of pain serious enough to require a substantial dosage and daily regiment of use, with the expectation that the drug will be used for extended periods of time. The key to Rexista, and why it may play a key role in a physicians decision to prescribe the drug, is that it has several abuse deterrent properties which make the drug almost tamper proof, and virtually impossible to take in a manner other than how prescribed.
Examples of the abuse deterrent properties in Rexista include proprietary methods that deter crushing, licking, melting, inhaling or injecting the drug. Additionally, Rexista will have properties that can tip the prescribing physician to potential signs of abuse, and provide further signals if the drug has been manipulated from its original form. Rexista will be the only abuse deterrent oxycodone product that will have the ability to provide these signals to the provider.
Future Milestone Possibilities For IPCI
IPCI has other pipeline candidates in que that hold potential for additional near term milestones, specifically their NDA 505(b)(2) specialty drug product candidates. These include Rexista® ER, based on its proprietary nPODDDS™ technology , and Regabatin™ XR (pregabalin extended-release capsules). IPCI remains focused on current development efforts directed towards improving difficult-to-develop, controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway, and has further increased its research and development emphasis towards new product development, also facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both Rexista®and Regabatin™.
IPCI For Investors
As always, investors need to take the time to look at both the near and long term prospects for IPCI, taking into account the possibility that a drug candidate will not be approved. Despite the FDA providing leading indicators that they support approval, I have always found the FDA to live in a bizarro world of their own, and take caution to anything that makes itself out to be a sure thing.
While stocks like IPCI have a tendency to get bullied around by the market makers, make no mistake about it, the news today is fantastic and establishes IPCI as a long term contender in the development of abuse deterrent drugs. With the manner at which the FDA is already breathing down physicians backs to curb opioid prescriptions, Rexista is well placed at the right time.
Don’t let the IPCI haters sway you, and I do expect a few to emerge. This news by IPCI is a major accomplishment by the company, validating not only Rexista, but an entire platform of potential abuse deterrent compounds.
So, hush, little naysayers, a phase III will not be required, which was your battle call for months. You should have listened when IPCI clearly told investors that once they had demonstrated bioequivilency to Oxycontin, which they did, that the NDA would suffice. But, that’s what makes a market. And, while the spin doctors may pick and choose selective items for debate, the true fact of the matter is simple…the FDA liked what they were presented.
Disclosure: This article was written by Kenny Soulstring, and it reflects my own opinions and unique articulation. This article is not intended to offer investing advice, guarantee 100% accurate predictions or to be interpreted as providing a personal recommendation. What I can guarantee, though, is accurate research, thoughtful analysis and an enthusiasm about any stock that I cover.
Additional Disclosure: I am long IPCI and may purchase additional shares within the next 72 hours.
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