Opioids News and Research

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An opioid is a chemical that works by binding to opioid receptors, which are found principally in the central nervous system and the gastrointestinal tract. The receptors in these two organ systems mediate both the beneficial effects and the side effects of opioids.

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

BDSI announces over 50% enrolled in BEMA Buprenorphine Phase 3 study in chronic pain

BioDelivery Sciences International, Inc. announced today that enrollment of its Phase 3 trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain is on schedule, with over half of the needed subjects enrolled.

18 Feb 2011

Study: BPS is safe and effective for patients undergoing therapeutic endoscopy

Researchers from Korea report that, compared with conventional sedation, balanced propofol sedation using propofol in combination with midazolam and meperidine, provided higher health care provider satisfaction, better patient cooperation, and similar adverse event profiles in patients undergoing therapeutic endoscopic procedures.

16 Feb 2011

Study finds worse outcomes in workers undergoing spinal fusion surgery

For workers' compensation patients with chronic low back pain, spinal fusion surgery leads to worse long-term outcomes—including a lower rate of return to work—compared to nonsurgical treatment, suggests a study in the February 15th issue of Spine. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

16 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

Zogenix completes enrollment in ZX002 Phase 3 study in opioid-experienced adults with moderate to severe pain

Zogenix, Inc. announced today the completion of enrollment in its pivotal Phase 3 efficacy study (Study 801) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.

10 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

Progenics, Salix enter exclusive worldwide license agreement for RELISTOR

Progenics Pharmaceuticals, Inc. and Salix Pharmaceuticals, Ltd. today announced that they have entered into an exclusive worldwide (except Japan) agreement by which Salix has licensed rights to RELISTOR® (methylnaltrexone bromide).

7 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

Etanercept can restore responsiveness to pain-relieving effects of morphine: Study

A drug called etanercept can restore responsiveness to the pain-relieving effects of morphine in rats that have developed morphine tolerance, reports a study in the February issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

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

Frequency of analgesic drug errors in hospitals is nearly 3 per 1000 prescriptions: Study

The frequency of analgesic drug errors in hospitals is nearly 3 per 1,000 prescriptions, based on a study performed in a 631-bed tertiary care facility and published in The Journal of Pain, the peer-review journal of the American Pain Society.

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

Phase III study affirms safety and efficacy of Cumberland's Caldolor for post-operative pain

Cumberland Pharmaceuticals Inc. today announced the publication of data affirming the safety and efficacy of Caldolor® (ibuprofen) Injection in treating post-operative pain in hospitalized patients. A Phase III study published in the peer-reviewed journal Pain Practice concluded that IV ibuprofen significantly reduced both morphine use and self-reported pain intensity in patients recovering from abdominal hysterectomy compared to morphine alone.

27 Jan 2011

New study reveals illicit HGH use among young American male weightlifters

A new study published in The American Journal on Addictions reveals that illicit use of HGH has become common among young American male weightlifters.

21 Jan 2011

Pisgah to scale-up patent-pending form of hydrocodone

As Pisgah Laboratories, Inc. continues development of its lead abuse deterrent opioid product, it will soon begin scale-up of its patent-pending form of hydrocodone. Pisgah has developed a specialized salt form of hydrocodone which imparts abuse deterrent properties to a dosage product. Pisgah will manufacture its hydrocodone salt for clinical trials in their FDA / DEA registered facility.

19 Jan 2011

Cadence launches OFIRMEV pain medication in the U.S.

Cadence Pharmaceuticals, Inc. today announced the launch of OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. The U.S. Food and Drug Administration (FDA) approved OFIRMEV in November 2010 for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

18 Jan 2011

PecFent accepted in Scotland for treatment of breakthrough cancer pain

Archimedes Pharma Ltd., a leading international specialty pharma company, today announced the decision by the Scottish Medicines Consortium to accept PecFent for use within NHS Scotland. PecFent is indicated for the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain.

18 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

FDA calls for cuts in Acetaminophen in painkillers

The US FDA has asked for a limit on the amount of acetaminophen in prescription pain medicines in an effort to reduce the risk of liver damage. The announcement yesterday asked manufacturers to limit combination drugs such as the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and asked them to carry a “black box” warning about potential liver failure. At present these combinations carry up to 750 milligrams of acetaminophen.

13 Jan 2011