By Adam Feuerstein 06/24/11 - 08:06 AM EDT
another example why not to hold into FDA decision, money is made on the run into the event - surf
NEW YORK (TheStreet) -- U.S. regulators rejected Thursday a tamper-resistant painkiller from Pfizer(PFE) and Pain Therapeutics(PTIE), said U.S. Food and Drug Administration spokesperson Shelly Burgess Thursday night.
The Pfizer-Pain Therapeutics drug, Remoxy, is a long-acting opioid consisting of the narcotic oxycodone mixed with ingredients aimed at making it resistant to abuse and misuse.
Pfizer confirmed Remoxy's rejection in a statement issued Friday morning but would not disclose the reasons for why FDA decided against approval.
Durect Corp.(DRRX) is also responsible for some of the drug technology used in Remoxy and would have received royalties on sales had the drug been approved.
Pain Therapeutics closed Thursday at $9.24 a share but was down 35% to $6 a share in early Friday trading. Durect shares closed Thursday at $3.09 but were off 32% to $2.10 early Friday.
Pain Therapeutics has been seeking Remoxy's approval for more than three years and the drug was rejected by FDA once before, in 2008. Pfizer came on board the project when it acquired King Pharmaceuticals last year. King partnered with Pain Therapeutics in 2005 to help with Remoxy's development.
Pfizer and Pain Therapeutics could not be reached for comment Thursday night so it's not known what steps need to be taken at this time for Remoxy to be resubmitted for approval again.
Purdue Pharma already sells a tamper-resistant, long-acting form of oxycodone, so Remoxy's setback is a win for the privately held drug maker.
Last Friday, FDA approved Oxecta, a short-acting, tamper-resistant painkiller from Pfizer and Acura Pharmaceuticals(ACUR).
Recent SAVA News
- Cassava Sciences Issues Statement on Former Science Advisor • GlobeNewswire Inc. • 06/28/2024 07:58:09 PM
- Cassava Sciences Reports Q1 2024 Financial Results and Clinical Updates on Phase 3 Trials of Simufilam • GlobeNewswire Inc. • 05/10/2024 08:02:00 PM
- Cassava Sciences Announces Over $125 Million Raised from Warrant Distribution • GlobeNewswire Inc. • 05/08/2024 03:00:00 PM
- Tomorrow is Last Day to Trade SAVAW Warrants on NASDAQ • GlobeNewswire Inc. • 05/01/2024 01:10:00 PM
- Redemption Date Announced for Warrants • GlobeNewswire Inc. • 04/15/2024 01:20:00 PM
- Cassava Sciences Announces Completion of an Interim Safety Review of Oral Simufilam On-going Phase 3 Trials • GlobeNewswire Inc. • 03/25/2024 01:13:00 PM
- Cassava Sciences Announces Virtual Presentation at the AD/PD™ 2024 International Conference • GlobeNewswire Inc. • 03/04/2024 02:15:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/28/2024 09:01:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/28/2024 02:22:12 PM
- Cassava Sciences Reports Full-year 2023 Financial Results and Corporate Updates • GlobeNewswire Inc. • 02/28/2024 02:14:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/07/2024 02:20:27 PM
- No Decline in Cognition Scores in Patients with Mild Alzheimer's Disease Who Received Simufilam Continuously For 24 Months • GlobeNewswire Inc. • 02/07/2024 02:08:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/01/2024 09:00:47 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/26/2024 09:23:45 PM
- Cassava Sciences Completes Dividend Distribution of Warrants to Shareholders • GlobeNewswire Inc. • 01/05/2024 02:12:00 PM
- Form CERT - Certification by an exchange approving securities for listing • Edgar (US Regulatory) • 01/03/2024 09:24:43 PM
- Form 424B2 - Prospectus [Rule 424(b)(2)] • Edgar (US Regulatory) • 01/03/2024 09:22:52 PM
- Form 8-A12B - Registration of securities [Section 12(b)] • Edgar (US Regulatory) • 01/03/2024 09:18:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/03/2024 02:10:10 PM
- Form 8-A12G - Registration of securities [Section 12(g)] • Edgar (US Regulatory) • 01/02/2024 02:10:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/12/2023 02:19:07 PM
- Cassava Sciences Announces Dividend Distribution of Warrants to Shareholders • GlobeNewswire Inc. • 12/12/2023 02:13:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/11/2023 09:18:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/08/2023 10:06:37 PM
Panther Minerals Inc. Launches Investor Connect AI Chatbot for Enhanced Investor Engagement and Lead Generation • PURR • Jul 9, 2024 9:00 AM
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM