Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

An interesting PR today...


I think the upcoming research posters send some important messages, but there is not much new here, and we should be cautious not to over-interpret what it all means. First, these would have been planned many months ago, before reformulated SequestOx fed BE study results were known. It does say something that Nasrat did not pull them out (poster interruptus). If you're looking for some kind of signal that SequestOx development will continue, then now you have it loud & clear. Second, this does not appear to be new any data, but rather the same ELI-200 nasal abuse HAL study that was presented May 2016 at the annual meeting of the American Pain Society. But the data has been reworked for a different crowd at Painweek. Last year's meeting was more academic with more PhD's and MD/PhD's- a consortium of lab geeks, grad school nerds, and med school professors (also very dweeby). The upcoming meeting will be all docs who prescribe opioids for a living trying to learn a few things and pick up some CME hours for licensure. (In modern political parlance, last year's attendees represent the snobby coastal elites, and this year's group are the REAL MURKINS.)


In 2016, the poster was more about ELI-200 pharmacodynamics, but at this year's Painweek, it will be more about the abuse potential and effectiveness of SequestOx. It shows Nasrat thinking forward about who will be his target audience, and it shows he smartly plans to use the quality of the abuse deterrence as a marketing tool. I like the idea of exposing pain management docs to the idea that IR oxycodone with sequestered naltrexone has awesome abuse deterrence properties- the sooner and the more times they see it the better it will sink in.


Lastly, I'm not sure how much this represents a major new relationship for Elite or that it indicates the severing of ties with an old partner (although I'd be glad for either or both to be true). Rather, this shows that Elite continues to associate with Dr. Beatrice Setnik, who is a very well-respected scientist in the field. She was the primary author on the 2016 poster, and she is an executive at INC Research / inVentiv Health.






35th Annual Scientific Meeting of the American Pain Society
11 May 2016 - 14 May 2016:

http://www.jpain.org/article/S1526-5900(16)00449-1/abstract

(442) Pharmacodynamic data assessing the abuse potential of a novel abuse deterrent oxycodone formulation (ELI-200) compared to oxycodone immediate release, oral intact ELI-200, and placebo in healthy, non-dependent recreational opioid users following intranasal administration

B. Setnik, K. Schoedel, C. Bartlett, C. Dick, N. Hakim, P. Geoffroy
INC Research, Toronto, Ontario, Canada

http://exlevents.com/human-abuse-liability-abuse-deterrent-formulations/faculty/

Beatrice Setnik
VP, Scientific and Medical Affairs, INC RESEARCH / INVENTIV HEALTH
view speaker profile

Dr. Setnik has been working in the area of clinical drug development and abuse potential (AP) assessment since 2005. Dr. Setnik is currently the Vice President of Scientific & Medical Affairs at INC Research/ inVentiv Health, Early Phase and an Adjunct Professor with the Department of Pharmacology and Toxicology at the University of Toronto. Dr. Setnik earned her doctorate degree in Pharmacology and the Collaborative Program in Neuroscience from the University of Toronto in 2005. In her previous role as Senior Director, Clinical Sciences (King Pharmaceuticals and Pfizer, Inc), Dr. Setnik led the clinical development and lifecycle management — including the abuse potential evaluation — of several pain compounds, including abuse-deterrent opioid formulations. In her previous role as a Research Scientist (formerly Ventana/Decisionline Clinical Research, Toronto, Canada), Dr. Setnik was responsible for providing scientific input on various specialty phase I-II clinical trials including abuse potential studies for CNS drugs. Dr. Setnik has published numerous research articles in internationally recognized peer-reviewed journals and is a recognized expert in the area of abuse and dependence evaluation. In addition, she is a Managing Director of the Cross Company Abuse Liability Consortium and has been an active member since 2008. Dr. Setnik is also an active member and participant in several congresses including the College on Problems of Drug Dependence. She has been actively engaged in many aspects of abuse potential assessment, including the development of patient-reported outcome instruments, and contributes to post-marketing surveillance studies.