It's not good to go for licensing yet...they juz launched it and are adding it to Rexista ahead of the upcoming Rexista clinical trials yet to be announced k.
So yes, once the PODRAS platform tech is good to go per se then for sure it'll definitely be applicable to a wide variety of other drugs for licensing opportunities imo of course...based on all the comments already made by the CFO and CEO glty
Mopar, with all due respect, do you think you might be asking that the cart goes before the horse?
Who is going to fork over the kind of money a licensing deal would bring in on a perceived technology not validated by any clinical trials and non-approval by the FDA (here in the US) that the end point meets the criteria agreed upon to deter drug abuse of any kind with any drug?
To be clear, when the company develop the PODDD's tech. platform it dealt with the abuse of the drug by the braking down and altering the characteristics of the tablet for more blatant abuse. PODRA's deals with the intact tablet making sure the abuse doesn't come from overdose by an over-prescribed supply. Now we are set to prove all of this out through clinical trials.
In the last pr, the answer is in the details. Look at all the speculative wording the company used (highlighted in bold by me) on something they feel confident about to submit a patent for but hasn't been clinically proven yet.
We should hear from the company on the start of these clinical trials after the plan they agree to with the FDA with the end points they wish to achieve with a partnership in place.
The PODRAS™ platform technology is covered by patents pending with the U.S. Patent and Trademark office.
"We believe this significant advance in our abuse deterrence technology has the potential to positively differentiate Rexista™ from other abuse-deterrent technologies of which we are aware, and represents an important step toward helping patients manage their pain safely," said Dr. Isa Odidi, Chief Executive Officer of Intellipharmaceutics. "In addition to its use with oxycodone, the new technology is potentially applicable to a wide range of drug products that are intentionally or inadvertently abused and cause harm by overdose to those who ingest them."
Intellipharmaceutics' most advanced application of the PODRAS™ platform to date is to its Rexista™ product candidate (oxycodone hydrochloride extended-release tablet), which is designed to deter abuse by both physical interference and overdose.
Preclinical studies of Rexista™ suggest that, unlike other third-party abuse-deterrent oxycodone products, if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected, even possibly approaching zero. However, if the prescribed number of pills is swallowed, the drug release should be as expected.
In January 2013, the United States Food and Drug Administration ("FDA") published a paper titled, Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling, which cited the need for more efficacious abuse deterrence-technology.
In this draft Guidance, the FDA stated, "Opioid analgesics are often manipulated for purposes of abuse. Most abuse-deterrent technologies developed to date are designed to make product manipulation more difficult or to make abuse of the manipulated product less attractive or rewarding. However, these technologies have not yet proven successful at deterring the most common form of abuse - swallowing a number of intact pills or tablets to achieve a feeling of euphoria."
Dr. Ed Sellers, an internationally recognized clinical pharmacologist and Professor Emeritus, University of Toronto, and President of DL Global Partners commented "The risk of overdose due to taking more opiate analgesic than prescribed is a real one. The lack of delivery technologies to reduce that risk is an unmet public health need. The announced technology is promising.Confirmation of its clinical importance in human clinical studies would be a significant contribution to deterring abuse."
Intellipharmaceutics currently expects to begin a series of clinical trials in Canada and the United States in the coming months to further evaluate Rexista™ incorporating its PODRAS™ platform.
There can be no assurance as to whether or when the FDA will approve any Intellipharmaceutics' Rexista™ oxycodone application.
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