what a crack up!, page-41

Just to get the terminology aligned:

What POH plans to do is submit an IND (Investigative New Drug) application to the FDA as soon as the pharmacokinetic studies (multi-dose trials) are complete.

The company has stated that this IND will be submitted under FDA regulation 505(b)(2), which is a fast track pathway covering novel drug delivery of existing approved drugs. The IND application is comprehensive and complex, and the company has been working on this submittal for months under the guidance of a blue ribbon panel of experts including at least one key former FDA official.

FDA sign-off on the IND submitted under 505(b)(2) will allow the company to proceed in accordance with the process set out in 505(b)(2) - and that means straight to Phase III.

Here's what the company said in December 2011:

"The initial trial will characterise the pharmacokinetic dose profile of the new patch on healthy participants from both single and repeated applications. This data is required for our planned submission to the FDA, and forms a vital component of the product dossier. The preliminary trial will be conducted on 65 subjects and will continue through the first quarter of 2012.

"The results of these trials will be submitted to the FDA next year as part of an IND application in order to gain approval to conduct the late phase trials during the second half of next year. At this stage our pain advisory board recommends that we go straight from the initial trials to a Phase 3, leaving out a Phase 2 altogether.

"This is made possible by the 505(b)(2) application route, which is specifically designed to short cut the clinical and review process for drugs that the FDA has previously approved. Our advisory board includes ex-FDA pain division members as well as individuals and CROs who have been intimately involved in previous FDA registration of opioids. Their experience in this field is invaluable, and we will be guided by them to ensure the greatest probability of designing a trial program leading to successful applications with the FDA in the shortest possible time."

For your reference:

http://www.regprofessional.com/resources/505(b)(2).pdf

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079345.pdf

(note that despite the above document being self-described as a "draft" it has remained unaltered for years and is the latest version of the document offered on the FDA's own website)