***** Information is now posted for the Adcom this Wednesday. *****
Hello WeeZuhl and the ELITE board,
Intellipharmaceutics is having their Adcom THIS Wednesday in the AFTERNOON session for a new extended-release formulation of oxycodone, designed with properties intended to deter abuse.
This is a VERY important Adcom to pay attention to for ELITE shareholders as this will be the MOST up-to-date info on the FDA's thoughts about abuse-deterrent products and the current REQUIREMENTS in order to get an abuse-deterrent product approved.
The committees will discuss new drug application (NDA) 209653, for an extended-release oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., for the management of moderate-to-severe pain when a continuous, around-the-clock, opioid analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse deterrent properties for this product. The committees will be asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, as well as to discuss the overall risk-benefit profile of the product.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ HERE is the schedule for Wednesday for Intellipharmaceutics:
1:30 p.m. Call to Order and Introduction of Committee 1:35 p.m. Conflict of Interest Statement 1:40 p.m. FDA Opening Remarks 1:45 p.m. APPLICANT PRESENTATIONS Intellipharmaceutics Corp. 2:30 p.m. Clarifying Questions 2:45 p.m. FDA PRESENTATIONS 3:30 p.m. Clarifying Questions 3:45 p.m. OPEN PUBLIC HEARING 4:15 p.m. BREAK 4:30 p.m. Charge to the Committee 4:35 p.m. Questions to the Committee/Committee Discussion 5:30 p.m. ADJOURNMENT
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ HERE is the link to the FREE live webcast:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ HERE are the draft questions:
1. DISCUSSION: Please discuss whether the Applicant has demonstrated that AXIMRIS XR (oxycodone extended-release tablets) has properties that can be expected to deter abuse by the following routes:
1. Intravenous 2. Intranasal 3. Oral
2. DISCUSSION: The Applicant is requesting approval of AXIMRIS XR as an analgesic with properties expected to deter abuse by the intravenous route. Discuss the implications of approval of AXIMRIS XR that can be expected to deter abuse by a single route.
3. DISCUSSION: Discuss whether you have any concerns regarding the impact of AXIMRIS XR on public health. Take into consideration its potential effect on abuse of extended-release oxycodone as well as potential consequences of administration of this product by unintended routes.
4. DISCUSSION: Discuss whether the benefits outweigh the risks for the proposed indication. Discuss if any additional data are needed for this application to be approved.
5. VOTE: Do you recommend approval of AXIMRIS XR (oxycodone extended-release tablets) 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?
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ HERE is the link for all the information including the 127 PAGE FDA ADVISORY COMMITTEE BRIEFING DOCUMENT for Aximris XR extended-release tablets:
*** Open all the PDF links for the PM SESSION. The AM SESSION is for ANOTHER company.
Actually, it seems to me that "playing games" is exactly what IPCI is doing. There is (was?) a good trading opportunity going into Adcom, as there almost always is for NDA AdComs. However, if I was going to venture into those dark waters, I would most definitely get out & dry off BEFORE the AdCom. I would also point out that IPCI getting an AdCom for oxyER says ABSOLUTELY NOTHING about the abuse deterrent opioid market. Multiple ADF opioids have successfully navigated an AdCom and received FDA approval but either never launched or quickly discontinued. A few other facts to consider:
1. The poisonous blue dye in the first version of IPCI's oxyER was not a superfluous add-on. It had to be removed because it kills people in higher concentrations (You're welcome, America!). BUT, as poisonous as it is, the blue dye was a necessary component of the ADF because the drug can be chewed "like bubblegum," according to Dr. Odidi. Chewing is the most common route of abuse for ER opioids, and IPCI has never released the results of their chewing HAL studies. Without the blue dye, what is preventing anyone from chewing it, "like bubblegum"? If those HAL studies were successful, we would know about it by now, and we would be hearing about it over & over. No HAL results --> No confidence.
2. IPCI's Oxy ER is not Collegium's Xtampza. Collegium's drug is successfully challenging Purdue's OxyContin in the market because Xtampza is a totally unique formulation. It is superior to OxyContin in multiple ways but most especially in chewing resistance. Unlike Xtampza, IPCI's oxyER is an OxyContin clone. It has excellent syringeability data, which was revealed at the first AdCom, but we have never seen chewing or snorting HAL data. I highly doubt that IPCI's chewing data is even comparable to OxyContin, but even if it was, that would not get it approved. It has to be good enough to qualify for the same chewing ADF label that Xtampza has in order to be approved, and IMO, that is highly unlikely. And don't forget, IPCI's clone is still locked down in patent infringement litigation with Purdue.
3. The Odidi's recently expanded their loan to the company. If they had confidence in the drug's impending success, why wouldn't they buy shares instead giving another loan? Likewise, when the company was desperately trying to increase shareholder equity to maintain NASDAQ listing, the Odidi's never converted their loan to shares, which would have made the job much easier to accomplish. Dr. Odidi has also started a new venture in China. If the CEO shows no confidence in the future of the company, then why would I?
4. The "300% return in the past 4 weeks" (up to 58 cents) is the equivalent 5.8 cents for an entire generation of shareholders that bought their shares in the multi-dollar range prior to the reverse split. Wiped out. This is what ADF opioids have done for many shareholders in multiple companies. The fact that this has not happened to ELTP is entirely the result of preemptive actions taken by ELTP management.
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IMO, FDA will not look favorably on a chewable OxyContin clone. But if you have a strong stomach, be my guest. However, if you hold through the Adcom, I recommend wearing Pampers on January 15. Whatever happens to IPCI's drug on that day, it doesn't change the fact that the ADF opioid market has never developed as everyone hoped. With the exceptions of OxyContin and Xtampza, every other ADF drug is a miserable failure.
