Oxycodone News and Research

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QRxPharma granted FDA pre-NDA meeting, further phase II data released

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the granting of a pre-New Drug Application (NDA) meeting with the United States Food and Drug Administration (FDA) and successful completion of its third pivotal Phase 3 registration trial (study 009) for immediate-release MoxDuo.

20 Feb 2011

AP: Crooks find Medicare Part D an easy target

Crooks are taking advantage of lax oversight in Medicare's Part D prescription drug program to obtain highly addictive drugs including oxycodone, Ritalin, and methadone, according to results of a federal probe.

14 Feb 2011

FDA accepts King's ACUROX NDA for filing with Priority review classification

Acura Pharmaceuticals, Inc. today announced that it has been informed by King Pharmaceuticals Research and Development Inc. (King) that King's New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets was accepted for filing by the US Food and Drug Administration (FDA) with a Priority review classification and a Prescription Drug User Fee Act (PDUFA) date of June 17, 2011.

14 Feb 2011

Elite third quarter consolidated revenues increase 34% to $1.2 million

Elite Pharmaceuticals, Inc., a specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations, announced results for the fiscal third quarter ended December 31, 2011.

14 Feb 2011

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

Covidien, a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System (FTS) patch. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.

10 Feb 2011

Ameritox makes significant strides to advance its industry leadership position

Ameritox, the nation's leader in pain medication monitoring, made significant strides to advance its industry leadership position by strengthening the company's commitment to physicians and patients in the past twelve months.

5 Feb 2011

Waismann Method examines link between chronic pain and Opioid-Induced Hyperalgesia

Results from a recent study issued by the Substance Abuse & Mental Health Services Administration revealed that treatment admissions for prescription painkiller abuse rose 345 percent over a 10 year period extending from 1998 to 2008.

5 Feb 2011

FDA approves ANDA for phentermine HCl 37.5 mg tablets

Elite Pharmaceuticals, Inc. announced today the approval of an Abbreviated New Drug Application for phentermine HCl 37.5 mg tablets by the U.S. Food and Drug Administration. The phentermine HCl tablets are the generic equivalent of the Adipex-P 37.5 mg tablets.

4 Feb 2011

King Pharmaceuticals awards payment to Pain Therapeutics for abuse-resistant medications

Pain Therapeutics, today announced that it had received a $5,000,000 milestone payment from King Pharmaceuticals, its exclusive commercial partner for abuse-resistant prescription pain medications.

29 Jan 2011

New research: Retired NFL players more likely to misuse painkillers

Retired NFL players use painkillers at a much higher rate than the rest of us, according to new research conducted by investigators at Washington University School of Medicine in St. Louis.

28 Jan 2011

FDA accepts Pain Therapeutics NDA resubmission for REMOXY

Pain Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) resubmission for REMOXY (controlled-release oxycodone) and has classified it as a Class 2 resubmission.

27 Jan 2011

Covidien announces support for FDA on safe use of acetaminophen

Covidien, a leading global provider of healthcare products and the world's largest producer of acetaminophen, supports the U.S. Food and Drug Administration (FDA) on the safe use of acetaminophen.

14 Jan 2011

FDA asks manufacturers to eliminate higher-dose prescription combination acetaminophen products

The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams in each tablet or capsule.

14 Jan 2011

Study suggests new experimental drug is better than standard morphine

A little-known morphinelike drug is potentially more potent, longer lasting and less likely to cause constipation than standard morphine, a study led by a Loyola University Health System anesthesiologist has found.

5 Jan 2011

King Pharmaceuticals resubmits NDA for REMOXY

King Pharmaceuticals®, Inc. and Pain Therapeutics®, Inc. today announced that King has resubmitted a New Drug Application for REMOXY® to the U.S. Food and Drug Administration in response to a Complete Response letter received by Pain Therapeutics in December 2008.

28 Dec 2010

NDA resubmitted for DURECT's ORADUR technology based REMOXY

DURECT Corporation today reported that King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. 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.

28 Dec 2010

King submits ACUROX NDA to FDA

King Pharmaceuticals®, Inc. and Acura Pharmaceuticals, Inc. today announced that King has submitted a New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets to the U.S. Food and Drug Administration (FDA), including a request for priority review classification. ACUROX® is an immediate release tablet containing oxycodone HCl intended for the relief of moderate to severe pain.

20 Dec 2010

Preliminary results from Phase 1b/2a trial of MediciNova's ibudilast in opioid addicts announced

Drug addiction investigators with joint appointments at Columbia University Medical Center and the New York State Psychiatric Institute along with MediciNova Inc, a biopharmaceutical company publicly traded on the Nasdaq Global Market and the Jasdaq Market of the Osaka Securities Exchange, today reported preliminary results of the company's neurological drug candidate, ibudilast (MN-166/AV411), in a Phase 1b/2a trial in opioid addicts. The study was largely funded by the National Institute on Drug Abuse (NIDA) with MediciNova supplementation.

14 Dec 2010

BDSI initiates dosing in BEMA Buprenorphine Phase 3 clinical program for chronic pain

BioDelivery Sciences International, Inc. today announced the enrollment and dosing of the first patient in its Phase 3 clinical program evaluating the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain.

9 Dec 2010

QRxPharma completes patient enrolment of pivotal MoxDuo IR phase 3 study

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today it has completed patient enrolment for a pivotal Phase 3 registration trial (Study 009) for MoxDuo IR. The comparative study was designed to evaluate analgesic efficacy and safety of MoxDuo IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone, for managing moderate to severe pain in patients who have undergone total knee replacement surgery.

5 Dec 2010