Elite Pharmaceuticals Inc (OTCMKTS:ELTP) provided guidance on its Phase III trial for ELI-200. It is an abuse-deterrent opioid product. It has filed a study protocol to the FDA. It will begin with dosing for the study as soon as it receives FDA comments on the protocol. The comments are expected to come by mid-March following that dosing of study will be completed within a period of eight weeks.
The Phase III study
It is a randomized, double-blind, multiple-dose, placebo-controlled, parallel group and multi-center study to assess the safety and efficacy of ELI-200. The drug is meant for the treatment of patients with moderate to severe pain resulting from surgery. The trial will have almost 150 patients. Elite expects to file the NDA for ELI-200 in 3Q and, therefore, anticipates the NDA review to be completed by early 2016.
The additional studies
Elite Pharmaceuticals will conduct two additional studies to support product labeling. The first one will be a phase one, randomized, single-dose, open-label and three-way crossover trial to compare the bioavailability of lead candidate to the reference product as per the Fed guidelines in healthy people. Dosing of Phase one has been completed.
The second study
It is a randomized, multiple-dose, parallel group, and double-blind study to assess potential withdrawal effects after administration of ELI-200 compared to the reference drug in methadone-maintained opioid-dependent patients. The dosing of the second study has been initiated. Reports and results from both trials are expected to be presented before the completion of the Phase III study.
The management view
Elite Pharmaceuticals’s CEO, Nasrat Hakim, said that positive guidance is received from the FDA. There is a clear regulatory road ahead for ELI-200. The filing date is anticipated in 3Q2015. The FDA review leading to approval of ELI-200 is expected to be completed by 2016. The company is expanding its manufacturing facility so as to support the launch of ELI-200.