An orphan patch?

The possibility had escaped me before, but I wonder if POH can/would apply for Orphan Drug Designation if its upcoming Phase 2 trial of the TPM/oxycodone patch for post -herpetic neuralgia is successful?

Orphan drug incentives afforded by the FDA include

• a 50% tax credit on the cost of clinical trials undertaken in the USA
• waiver of PDUFA filing fees (set at $2.169 m. in 2014)
• a seven year period of marketing exclusivity following the marketing approval
• written recommendations provided by the FDA concerning clinical and preclinical studies to be completed in order to register the new drug
• a fast-track procedure for the FDA to evaluate registration files

Post herpetic neuralgia is classified as an orphan disease in the United States and there are several products in development, intended for the treatment of PHN, which have already been granted orphan drug designation by the FDA.

For example, Durect’s Eladur Bupivacaine patch was granted orphan drug designation by the FDA in 2008, on the strength of data generated from a Phase 2a trial. Although bupivicaine (a local anaesthetic, like lidocaine) is an approved drug, it had not previously been approved by the FDA for PHN indication. In 2010, EpiCept Corporation was granted orphan drug designation for NP-1, a prescription topical analgesic cream, for the treatment of PHN. Finally, Zalicus Inc.received Orphan Drug designation last year for Z160, an oral, calcium channel modulator for the management of PHN.

Orphan drug designation is possible for an already approved drug in a new use, as occurred in the case of Durect's bupivacaine patch (bupivacaine first came to market 50 years ago). I note that although oxycodone is considered the “gold standard” opioid treatment option for PHN, it has not previously been approved by the FDA in this indication.

http://www.orpha.net/consor/cgi-bin...TION_EDUCATION_ABOUTORPHANDRUGS_USA#providers

http://www.fda.gov/downloads/ForInd...easesConditions/OOPDNewsArchive/UCM294786.pdf

http://www.durect.com/wt/durect/page_name/pr_1214840585

http://www.news-medical.net/news/20...PHN-receives-FDA-orphan-drug-designation.aspx

http://www.businesswire.com/news/home/20130927005456/en/Zalicus%E2%80%99-Z160-Receives-Orphan-Drug-Designation-Management#.VGHEYDSUcf0