Elite Pharmaceuticals Inc (ELTP)

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Elite Pharmaceuticals Provides Guidance On Phase III Study For ELI-200

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=75450&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0

NORTHVALE, N.J., Feb. 17, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP) announced guidance today regarding the Company's Phase III trial for ELI-200, an abuse deterrent opioid product. Elite has submitted a study protocol to the FDA and dosing for the study is expected to begin shortly after the FDA comments on the protocol are received by Elite. The Company anticipates that it will receive the FDA comments by mid-March and that dosing will take approximately eight weeks to complete.

The Phase III study is a multi-center, randomized, multiple-dose, double-blind, placebo-controlled, parallel group, study to evaluate the efficacy and safety of abuse deterrent ELI-200 for the treatment of adults with moderate to severe pain following surgery. The study will enroll approximately 150 patients. We anticipate filing the ELI-200 NDA in Q3 and therefore expect the NDA review by FDA to be completed by early 2016.

https://clinicaltrials.gov/ct2/show/NCT02401750?term=%22Elite+Laboratories%2C+Inc%22&rank=2