Elite Plans Opioid NDA Submission After Phase III Success
This article was originally published in Scrip
Executive Summary
Elite Pharmaceuticals plans to submit a new drug application (NDA) to the US FDA by the end of this year based on positive Phase III results in the treatment of moderate to severe pain for ELI-200, an opioid-based pill designed with the company's proprietary abuse-deterrent technology (ART).
You may also be interested in...
Sage’s Dalzanemdor Prospects In Doubt After First Mid-Stage Readout
Dalzanemdor (SAGE-718) showed no difference from placebo in a Phase II Parkinson’s disease study, raising concerns about readouts later this year in Huntington’s and Alzheimer’s diseases.
First Phase III Depression Data For Intra-Cellular’s Caplyta Exceed Expectations
With positive results from the first Phase III trial of lumateperone in major depressive disorder and a second readout expected later this quarter, the company plans a supplemental filing in late 2024.
Finance Watch: Ten IPOs So Far In 2024, But Returns To Date Are Subpar
Public Company Edition: This year’s newly public companies are trading an average of 9.7% below their IPO prices, including the two most recent debuts, Boundless Bio and Contineum. Also, Nkarta, Praxis and Nurix grossed $240m, $200m and $175m, respectively, in follow-on offerings.