IntelliPharmaCeutics International Inc. (NASDAQ: IPCI)
IntelliPharmaCeutics is having an incredible day in the market today after announcing data from recent trials. Today, we’ll talk about what the data is, what we’re seeing in the market as a result, and what we can expect to see from IPCI moving forward.
IntelliPharmaCeutics Releases Bioequivalence Trial Data
Early this morning, IPCI announced the results of bioequivalence trials of Rexista Oxycodone XR extended release tablets. The study was designed around recommendations by the United States FDA comparing the lowest and highest strengths of Rexista Oxycodone XR to the same strengths of Oxycontin. Through the study, IPCI proved that ratios of the pharmacokinetic metrix, Cmax, AUCO-t and AUCO-f for Rexista in comparison to Oxycontin were within the FDA required intervals of 80% and 125% and that a confidence level had exceeded 90%.
This is incredibly important data because it means that IPCI will not need to conduct a Phase 3 study on the drug. In May of 2015, the FDA notified IntelliPharmaCeutics that it would not need to complete a Phase 3 study on the drug if bioequivalence to Oxycontin was demonstrated. As a result of meeting this requirement, IPCI will forego Phase 3 trials of the treatment and expects to submit a New Drug Application to the FDA within the next 6 months. In a statement, Dr. Isa Odidi, CEO and co-founder of IPCI, had the following to say:
“We take great pride in being the first pharmaceutical company, to the best of our knowledge, to have demonstrated bioequivalence in both fasted and fed conditions to the brand reference drug Oxycontin. This enables us to accelerate the development and commercialization of our abuse different Rexista Oxycodone XR product candidate without the need for costly and time-consuming Phase 3 efficacy trials… We look forward to filing an NDA within the next six months, which we hope will lead to a positive contribution in addressing an unmet need in opioid abuse and addiction.”
How The Market Reacted To The News
Over the years, we have learned that when positive news comes out with regard to a publicly traded company, we can expect to see a positive response in the market. That’s exactly what’s happening with IPCI as the result of today’s announcement. Currently (10:15), IPCI is trading at $2.41 per share after a gain of 13.63% so far today.
What We Can Expect To See Moving Forward
Moving forward, I am confident that we will see bullish activity out of IPCI. First off, it’s not a common occurrence when the FDA is so confident with regard to a treatment that they allow pharmaceutical companies to skip required clinical trials. However, with Oxycontin and other opiod addictions being a major issue in the United States, there is a dire need for this treatment. As a result, the FDA is allowing this to happen. Considering that, I’m expecting to see two catalysts this year. First and foremost, when IPCI submits its NDA, we can expect investors to be excited, leading to gains. Also, when the FDA approves the treatment, we’re likely to see dramatic growth on the stock. Of course, we are likely to see slow and steady growth between the catalysts as well.
What Do You Think?
Where do you think IPCI is headed moving forward? Let us know your opinion in the comments below!
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