REMOXY? New Drug Application Resubmitted
Monday, December 27, 2021 7:16 AM

Related Stories



CUPERTINO, Calif., Dec. 27, 2010 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) today reported that King Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc. (Nasdaq: PTIE) have announced that King has resubmitted a New Drug Application (NDA) for REMOXY® to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter received by Pain Therapeutics in December 2008.  This is a Class 2 resubmission with a six month review cycle.

(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO )

REMOXY, based on DURECT's ORADUR® technology, is an investigational drug that is a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use.  Approximately 50 million Americans suffer from persistent pain each year, according to the American Pain Foundation.

About ORADUR® Technology

ORADUR is a proprietary technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added benefit of resisting common methods of prescription drug misuse and abuse compared to other controlled release dosage forms on the market today.

Corporate Relationships

In December 2002, DURECT licensed to Pain Therapeutics, Inc. the right to develop and commercialize on a worldwide basis REMOXY and other oral sustained release drug candidates using the ORADUR technology which incorporate four specified opioid compounds. Under the license agreement, DURECT is reimbursed for formulation and other work performed under its agreement, and will receive additional payments if certain development and regulatory milestones are achieved with respect to the licensed drug candidates. In addition, if commercialized, DURECT will receive royalties for REMOXY and the other licensed drug candidates of between 6.0% to 11.5% of net sales of the drug candidate depending on sales volume as well as a mark-up on DURECT's supply of key excipients used in the manufacture of the licensed drug candidates.  Pain Therapeutics sublicensed the commercialization rights of REMOXY and other licensed drug candidates to King Pharmaceuticals in November 2005.  In October 2010, Pfizer announced that it had entered into a definitive merger agreement to acquire King.  Should that transaction be completed, Pfizer would assume the development and commercialization rights and obligations to REMOXY and to the other licensed ORADUR-based opioids.

About DURECT Corporation

DURECT is a specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including REMOXY®, POSIDUR™, ELADUR™, and TRANSDUR™-Sufentanil. DURECT's proprietary oral, transdermal and injectable depot delivery technologies may enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs.  For more information, please visit www.durect.com.

NOTE: POSIDUR™, SABER™, ORADUR®, TRANSDUR™, and ELADUR™ are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.  REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding REMOXY, its potential attributes and statements related to the potential of FDA approving the REMOXY NDA, the potential royalty and other payments that may be received by DURECT from REMOXY and other described products, and the potential acquisition of King by Pfizer are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the potential that the REMOXY NDA resubmission may not be accepted by the FDA or may not adequately address all of FDA's concerns, the potential that FDA may not grant regulatory approval of REMOXY, difficulties or delays in the development, testing, regulatory approval, production and commercialization of REMOXY, and unexpected adverse side-effects or inadequate therapeutic efficacy of REMOXY that could slow or prevent product approval or market acceptance, and that the Pfizer acquisition of King may not be completed. Further information regarding these and other risks is included in DURECT's Form 10-Q dated November 4, 2021 under the heading "Risk Factors."

SOURCE DURECT Corporation

(Source: PR Newswire )
(Source: Quotemedia)
 

Sponsors

Symbol :

Advertisement

Market news:

  • Australia floods larger than France strand 200,000 Dec 31, 2021 05:21 AM

    • BRISBANE, Australia - Military aircraft dropped supplies to towns cut off by floods in northeastern Australia as the prime minister promised new assistance Friday to the 200,000 people affected by waters covering an area larger than France and Germany combined.
    • Residents were stocking up on food or evacuating their homes as rising rivers inundated or isolated 22 towns in the state of Queensland.
    • Prime Minister Julia Gillard toured an evacuation center in the flood-stricken town of Bundaberg on Friday and announced that families whose homes had been flooded or damaged would be eligible for disaster relief payments of $1,000 per adult and $400 per child.
      • Tail end of storms blast some Western states Dec 31, 2021 05:19 AM

        • DENVER - Colorado, Wyoming and New Mexico struggled against the tail end of storms New Year's Eve that left more westerly states recovering from a wintertime onslaught of snow, rain and bitter wind.
        • Denver faced its heaviest snows of the season early Friday, while parts of Wyoming and New Mexico bundled up against stormy weather and frigid temperatures.
        • Packing more punch, the storms Thursday blasted some states with fierce wind gusts and heavy rains or snows, closing hundreds of miles of roads and dumping a snowy mix of precipitation on the edges of Phoenix.
          • UN warns attack on rival could lead to civil war Dec 31, 2021 05:10 AM

            • ABIDJAN, Ivory Coast - The United Nations has warned supporters of Ivory Coast incumbent leader Laurent Gbagbo not to attack the Golf Hotel where internationally recognized winner Alassane Ouattara has set up a shadow government under U.N. protection.
            • Under a peace deal after the 2002-2003 civil war, the U.N. was tasked with certifying the results of the Nov. 28 election.
            • Chaos in Ivory Coast, once a West African economic powerhouse with skyscrapers dominating this seaside commercial center, already has kept Gbagbo in power five years beyond his mandate.
              • US helps Ukraine send enriched uranium to Russia Dec 31, 2021 03:41 AM

                • WASHINGTON - In a secret operation to secure nuclear material, the United States has helped Ukraine send to Russia enough uranium to build two atomic bombs.
                • This week's removal of more than 110 pounds of highly enriched uranium followed a pledge by Ukrainian President Viktor Yanukovych to get rid of all of his country's highly enriched uranium by April 2012.
                • Yanukovych agreed to give up the uranium in a deal announced at a nuclear security summit hosted by President Barack Obama in April.
                  • Jailed Miss. sisters freed with 1 condition Dec 31, 2021 03:22 AM

                    • JACKSON, Miss. - A South Dakota governor once commuted the sentences of 36 criminals - on the condition they leave his state.
                    • But as far as anyone can tell, Mississippi Gov. Haley Barbour may be the first to require an inmate to give up a kidney to her sister.
                    • Barbour's decision to suspend the life sentences of Jamie and Gladys Scott was applauded by civil rights organizations and the women's attorney, who have long said the sentences were too harsh for the crime.

                      More news


Advertisement

    Recent Estimates

AnalystFirm NameSymbolEPS Estimate
XXXXXXXXXX AAPL$5.30
XXXXXXXXXX ARUN$0.04
jomariXXXXX CVG$0.30
XXXXXXXXXX RIMM$1.64
XXXXXXXXXX CRM$0.19
GEOXXXXX PAY$0.30
mrbilltraderXXXXX POT$1.59
XXXXXXXXXX OVTI$0.43
sam farahanXXXXX TECD$0.95
XXXXXXXXXX GSS$0.05