US FDA again turns down approval of Pfizer and Pain Thera's Remoxy

28 June 2011

Pain Therapeutics (Nasdaq: PTIE) saw its shares plummet last Friday when, along with development partner global drugs behemoth Pfizer (NYSE: PFE) it announced that it had received a Complete Response Letter from the US Food and Drug Administration on the resubmission to the New Drug Application for Remoxy (oxycodone) extended-release capsules CII.

Pain Therapeutics received a complete response letter for its initial filing for Remoxy in 2008, and filed a response in December. Pfizer gained rights to the drug through its recent acquisition of King Pharmaceuticals, which had a licensing deal with Pain Therapeutics.

The news was a significant disappointment for Pain Thera, which plunged 43% to $5.30 on the Nasdaq, in its biggest decline since the company first went public in July 2000. Pfizer fell 2.8% to $20.08 on the New York Stock Exchange.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK