Elite Pharmaceuticals Inc (ELTP)

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The FDA continuing to push ADT opioids.......

STATE OF THE INDUSTRY – AN FDA REGULATORY EXPOSITION
2017 CBI Abuse-Deterrent Formulations Summit

http://abusedeterrent.org/Resources/Docs/CBI%20Throckmorton%20Blog%203-8-16.pdf

The keynote presentation for this year’s CBI - ADF conference was delivered by Dr. Douglas Throckmorton. His presentation summarized the key learnings from recent FDA public and advisory meetings, and illustrated how the FDA has supported the development and use of ADF technologies. Dr. Throckmorton’s presentation also addressed the current regulatory landscape and some of the nuances of the regulatory process. His remarks suggest FDA is trying to move forward with ADF approvals, but this arena poses unique and complex challenges including a most difficult issue: not knowing the quantitative impact of ADF products on opioid abuse.
Abuse Deterrent Coalition chair Dan Cohen introduced Dr. Throckmorton and highlighted 4 subject areas of key interest to the ADF industry. These issues were all touched upon, but much work remains to obtain detailed answers:
1. How with the FDA implement the “Incremental improvement” standard, as the Agency has resisted product approvals using that standard?
2. What is the time frame for the publication of the Generic Draft Guidance?
3. Is the Agency using the appropriate standards to measure Immediate-Release ADF? Are the standards used for Section 9.2 labeling too Extended Release/Long Acting oriented?
4. What is the reasoning and rational behind the Morphabond/Arymo Exclusivity decision?
Dr. Throckmorton began his presentation by telling conference attendees that ADF technology is one of the topics he finds most interesting and that he was struck by the number of companies that he did not recognize on the agenda. He feels this is a strong indication that new players and new technologies are entering the marketplace. Throckmorton noted that this is a positive step, because new competition and new technologies will move the entire industry forward.
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Dr. Throckmorton’s presentation was broken into four primary sections:
1. Background
2. Context
3. FDA action plan
4. And Focus on ADF opioids
Throckmorton noted that the FDA’s work to improve the safe use of opioids is taking place within a larger policy framework that aimed at addressing the opioid epidemic in its entirety. He and his colleagues at the FDA are seeing a small downward trend in the number of opioid prescriptions being written. They believe this indicates a more thoughtful approach to the prescription of opioids. Despite this downward trend, the FDA is still seeing an upward trend in the number of opioid deaths. Deaths due to prescription opioids, however, has remained flat.
Throckmorton highlighted a few consequences of opioid abuse. He noted that pockets of the country are more susceptible to HIV and IDU due to needle sharing and that there has been an increase in neonatal abstinence syndrome in states most adversely affected by the opioid epidemic, such as West Virginia. Throckmorton ended this section of his presentation by discussing the high degree of complexity that results from the overlap of multiple social factors that characterize opioid epidemic.
Throckmorton outlined the FDA’s two goals for regulation in the ADF space:
1. To incentivize the development of opioids with better ADF technologies and support the widespread use of those technologies
2. Assure the appropriate development and availability of generic ADFs
Dr. Throckmorton says the FDA helps further these goals through scientific research, regulatory activities, guidances, and public discussions and comments. He also noted that generic guidance will come as soon as possible.
Dr. Throckmorton outlined some of the recent accomplishments in the ADF space as a result of regulatory activity:
? Nine new opioids with ADF tech on the market
? Many new approaches to ADF are being explored
? There are more than 30 active INDs being discussed for ADFs
Dr. Throckmorton said that the agency needs data that shows ADF’s have an impact on real world abuse. This data will help the agency determine which technologies
work and which technologies don’t work. In the absence of this data, it is very hard to parse out data that proves ADFs work.
In the Q&A session, Throckmorton reiterated that he holds the personal belief that ADF’s have a positive, real world impact, but that as a doctor and regulator he doesn’t have the data to back up that personal belief. From his belief that ADFs work, comes his continued support for ADF and generic products.