Replies to post #67737 on ORIONS Money Stocks

[AugustaFriends]

CRXX ($.97) Charts Target $1.40 there is a GAP up there.

[AugustaFriends]

CRXX pending FDA drug approval --

http://www.combinatorx.com/products_pain_exalgo.php


Exalgo™ (hydromorphone HCl) Extended-Release Tablets (CII)
Exalgo is an extended release formulation of hydromorphone. Hydromorphone is a Schedule II opioid that has been used for many years. Oral hydromorphone products currently available in the U.S. are immediate release formulations, requiring dosing several times per day. Exalgo employs the OROS® PUSH-PULLTM osmotic delivery system designed to release hydromorphone at a controlled rate over an extended period of time allowing for once-daily administration. An identical once-daily formulation, under the trade name JURNISTA®, has been launched in several countries by Janssen-Cilag. JURNISTA® was first launched in Germany in August 2006.

To date, Exalgo has been studied in more than 2,000 patients in clinical trials. The most common adverse events seen in those clinical trials to date are opioid-related events such as constipation, nausea, somnolence, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including Exalgo.

On May 22, 2009, Neuromed submitted a response to an Approvable Letter to the U.S. Food and Drug Administration seeking approval for Exalgo for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. On June 12, 2009, the FDA informed Neuromed that the Exalgo submission would be classified as a Complete, Class 2 Response with a corresponding PDUFA date of November 22, 2009.

The U.S. commercial rights to Exalgo were acquired in June 2009 by Mallinckrodt, Inc., a subsidiary of Covidien, plc. Under the agreement, Covidien’s subsidiary Mallinckrodt Inc. will be responsible for all commercialization activities for Exalgo in the United States, including marketing and sales. Neuromed will work to complete the clinical development and the regulatory approval process. Covidien’s subsidiary Mallinckrodt Inc. will be responsible for all regulatory filings post-FDA approval.