This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Pfizer, Acura Painkiller Approved by FDA

Stocks in this article: PFE ACUR PTIE

NEW YORK ( TheStreet) -- Pfizer (PFE) and Acura Pharmaceuticals (ACUR) confirmed Monday the U.S. approval of a new tamper-resistant painkiller.

Acura shares were up $2.52, or 65%, to $6.39 in Monday pre-market trading.

The U.S. Food and Drug Administration approved the new opioid painkiller Oxecta on Friday night, but you wouldn't have known it unless you were logged on to Twitter.

Oxecta is a short-acting painkiller consisting of the narcotic oxycodone mixed with ingredients developed by Acura that make it hard for drug addicts to crush or dissolve the tablet to get a quick high. Pfizer will sell Oxecta -- formerly known as Acurox -- in the U.S. and give Acura milestone payments and royalties based on sales.

Oxecta discourages common methods used by addicts to tamper and abuse narcotic painkillers but the drug does not stop abuse altogether, Pfizer and Acura said in announcing the drug's approval.

The FDA does not allow claims of abuse deterrence without data from long-term epidemiological studies that can demonstrate reductions in drug abuse. What the FDA will allow, however, is data and language describing the tamper-resistant qualities of the drug and results from studies that simulate abuse.

The U.S. Food and Drug Administration approved Oxecta late Friday, confirmed spokeswoman Karen Riley, but the agency chose not to make a public statement. Pfizer and Acura didn't say anything publicly about Oxecta's approval on Friday either, choosing to wait for Monday to issue a press release.

With none of the involved parties willing to speak about Oxecta, the public announcement of the drug's approval was made by Geoff Chambers, an economist and biotech stock blogger who tweets under the handle @Gekkowire.

Chambers tweeted "$ACUR approved" at 8:46 pm EDT after getting an email confirmation from FDA spokeswoman Riley.

Oxecta is the first immediate-release opioid approved for the relief of moderate-to-severe pain that is also designed to deter common methods of misuse and abuse. The "typical" patient for such a drug would be someone who just had root canal or some other type of surgery and needs a painkiller for a short period of time -- a few days or up to one month.

Relatively cheap generic drugs currently dominate the market for short-acting opioid pain relievers, so Pfizer and Acura will need the drug's label to adequately describe Oxecta's tamper resistance in order to justify premium pricing.

Extended release, or long-acting, opioids that also aim to deter abuse are already on the market for patients who suffer from chronic pain. Purdue Pharma sells a tamper-resistant form of its popular Oxycontin. Pfizer and Pain Therapeutics (PTIE) expect an FDA approval decision on June 23 for Remoxy, another long-acting abuse-resistant opioid.

Acura has been trying to get Oxecta, then known as Acurox, approved since January 2009. The FDA first rejected the drug in June 2009. In April 2010, an FDA advisory panel voted against recommending the drug's approval. Acura and King Pharmaceuticals reformulated Oxecta/Acurox and resubmitted it for approval in December 2010. Later, Pfizer acquired King and took over marketing responsibilities for the Acura partnership.

Pfizer will pay royalties ranging from 5% to 25% to Acura, based on levels of sales of Oxecta and other drugs included in the partnership.

-- Written by Adam Feuerstein in Boston.



>To contact the writer of this article, click here: Adam Feuerstein.

>To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein.

>To submit a news tip, send an email to: tips@thestreet.com.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs