Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Remoxy AdComm

Pain not expecting an approval after Remoxy documents posted this morning???!!!!!!

I'm not sure if this is going to go well for our competitor, PTIE. The FDA has been suggesting for at least two years now they would not likely approve a new product that is less abuse deterrent than an existing product. That means something different for new product NDA's vs generic product ANDA's. Currently, there are no approved generic ADF's. The FDA guidance is that any generic will have to be at least as abuse-deterrent as the brand name product. For example, generic OxyContin ANDA applicants will be required to have snorting and IV abuse ADF labels but not oral/chewing ADF label, because OxyContin does not have that label. I suspect that may be what is holding up any generic OxyContin approval among the handful of sponsors who have beaten Purdue in court. This is less clear cut for an NDA applicant, and the FDA guidance language is intentionally vague. The usual understanding, however, is that FDA will not approve a new product if there is a comparable product that is more abuse deterrent. Collegium's Xtampza sets the standard on this now, since it proudly wears all three ADF labels. When Xtampza got the chewing label, I believe it became an uphill battle for any 12 hour oxy ER product that does not qualify for all 3 ADF labels. There definitely is some wiggle room, and, as we all know, FDA doesn't throw an AdComm party if they've already typed up the CRL. But this is the exact kind of issue that the Advisors on the committee will "bulldog." They're going to clamp down on this lack of an oral abuse deterrence claim and they'll chew it up relentlessly for hours before they spit out the mangled mess.



https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM611480.pdf

DRAFT QUESTIONS

1. DISCUSSION: Please discuss whether the Applicant has demonstrated that Remoxy ER (oxycodone extended-release capsules) has properties that can be expected to deter abuse, commenting on each of the following routes of abuse:
a. Oral
b. Nasal
c. Intravenous

2. DISCUSSION: Please discuss whether there are sufficient data to support inclusion of language regarding abuse-deterrent properties in the product label for Remoxy ER,commenting on support for abuse-deterrent effects for each of the following routes of abuse:
a. Oral
b. Nasal
c. Intravenous

3. DISCUSSION: The Applicant is requesting approval of Remoxy ER as an analgesic with properties expected to deter abuse by the intravenous, and intranasal routes. Discuss whether you have any concerns regarding the impact of Remoxy ER 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. VOTE: Based on the data presented and the discussions about the data, do the efficacy, safety and risk-benefit profile of Remoxy ER support the approval of this application?

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf

As with all NDA products, FDA intends to consider opioids with abuse-deterrent properties within the context of available therapy. The standard against which each product’s abuse deterrent properties are evaluated will depend on the range of abuse-deterrent and non-abuse deterrent products on the market at the time of that application

http://www.courant.com/news/connecticut/hc-news-stamford-opioids-spoon-sculpture-0623-story.html

A Stamford art gallery owner was arrested and charged with a criminal misdemeanor and a felony Friday morning after dropping an 800-pound steel sculpture of a bent, burnt heroin spoon in front of Purdue Pharma, a top manufacturer of opioids, and then refusing to remove it.