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Astute investors have an immense opportunity on their hands. Durect (NASDAQ:DRRX), Pain Therapeutics (NASDAQ:PTIE) and Pfizer (NYSE:PFE) ar all awaiting vital input from the FDA regarding their potential billion dollar drug (Remoxy).

DURECT awaiting Pfizer meeting with FDA on Remoxy
DURECT has a lot riding on a meeting in late March between its marketing partner, Pfizer, and the FDA to discuss resubmitting a new drug application for its lead pain drug, Remoxy, as a tamper-resistant formulation of oxycodone, a powerful opioid that is widely abused.

"Based on the feedback Pfizer receives from the FDA at that meeting, Pfizer will determine the next steps and/or required timing to respond to the Complete Response Letter for Remoxy," Matt Hogan, CFO of DURECT, says in an interview with BioTuesdays. He gave this interview following his presentation at the BIO CEO conference in New York earlier this month.

Remoxy, a re-formulation of Oxycodone, is an abuse deterrent.


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As you can see from the above image it is nearly impossible to abuse this drug. This fundamental difference would make the highly addictive first generation of Oxycodone nearly obsolete.

So what is Remoxy worth?


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The market for Remoxy is enormous as shown in this graph. Sales of Oxycodone have increased year after year. Durect is entitled to 6.0% to 11.5% royalties on worldwide sales of Remoxy. It will also be filing a New Drug Application (NDA) for Posidur in early April. Posidur is a long acting local anesthetic being developed for the treatment of post surgical pain. You can read more about it here.

Pain Therapeutics is entitled to 15% royalties on the first $1 Billion in sales of Remoxy and 20% thereafter. It has 2 other Phase I narcotic abuse deterrent products. It is imperative that Remoxy gets approved for the ongoing health of the company. The company does have a significant buffer, however, as it has over $1.20 cash per share.

Conclusion

This is a speculative play, riding on the input of the FDA meeting. These 2 stocks are in the drivers seat, with Pfizer at the helm.

DRRX, based on the above numbers, has 101,881,728 outstanding shares at a share price of $1.33. My price target on Durect is $3.00-$3.50. (taking into consideration their vast pipeline)

PTIE, based on the above numbers, has 45,332,131 outstanding shares at a share price of $3.72. My price target on Pain Therapeutics is $8.00-9.00.

If the FDA meeting is negative, the price per share could easily be cut in half from the current closing price.

Pain Therapeutics and Durect Corporation both present strong speculative opportunities, and are both a strong buy at the current price per share. These stocks could be the biggest gainers in your portfolio for 2013.

Source: Durect Corporation And Pain Therapeutics Big Gainers For 2013?