![](https://investorshub.advfn.com/uicon/350406.png?cb=1547729749)
Tuesday, March 21, 2017 6:18:53 PM
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=82925&GoTopage=1&Category=2163&BzID=2258&t=2086&G=939
"We are very pleased that the meeting discussions with the FDA provide a clear path forward for SequestOx™," said Nasrat Hakim, President and CEO of Elite. "Based on the guidance received from the agency, we plan to initiate the bridging studies immediately and are expecting to resubmit our NDA this year."
Elite Pharmaceuticals, Inc. Initiates Pivotal Bioequivalence Fed Study For Reformulated SequestOx™
NORTHVALE, N.J., March 13, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP), announced today that it has initiated pharmacokinetic testing of its reformulated SequestOx™. The reformulated product is expected to have a shorter Tmax under fed conditions. Elite is conducting a bioequivalence study which is a pivotal, open-label, randomized, single-dose, three-way, crossover study to evaluate the relative comparative bioavailability and bioequivalence of the modified formulation of SequestOx™ to the original formulation of SequestOx™ and to a comparator product under fed conditions. The study has enrolled forty-five healthy volunteers and the first subjects have been dosed.
SequestOx™ is Elite's investigational immediate-release oxycodone with sequestered naltrexone abuse-deterrent opioid product for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
"We are pleased to have this bioequivalence study underway for SequestOx™," commented Nasrat Hakim, President and CEO of Elite. "We are expecting results for this study by the middle of May and re-submitting the NDA prior to the end of the year."
Fear Uncertainty and Doubt FUD It Ain't Going To Work Here Anymore. Notice the lack of question mark.
Recent ELTP News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/05/2024 08:07:15 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/20/2024 08:30:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 09:55:26 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/29/2023 07:21:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/26/2023 09:20:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/12/2023 09:20:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/28/2023 12:05:38 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/27/2023 11:58:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/27/2023 11:50:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration with ZenaDrone • InvestorsHub NewsWire • 11/16/2023 12:32:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/25/2023 08:15:15 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/07/2023 08:05:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2023 09:30:05 PM
- Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 07/31/2023 08:20:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/17/2023 08:15:16 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/29/2023 09:15:09 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 06/29/2023 08:43:45 PM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM
ECGI Holdings Targets $9.7 Billion Equestrian Apparel Market with Allon Brand Launch • ECGI • Jun 25, 2024 8:36 AM
Avant Technologies Addresses Progress on AI Supercomputer-Driven Data Centers • AVAI • Jun 25, 2024 8:00 AM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM
Bemax Inc. Positions to Capitalize on Industry Growth with New Improved Quality of Mother's Touch® Disposable Diapers • BMXC • Jun 24, 2024 8:00 AM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM