Fentanyl News and Research

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Fentanyl is a powerful synthetic opiate analgesic similar to but more potent than morphine. It is typically used to treat patients with severe pain, or to manage pain after surgery. It is also sometimes used to treat people with chronic pain who are physically tolerant to opiates. It is a schedule II prescription drug.

BDSI announces postponement of ONSOLIS U.S. relaunch

BioDelivery Sciences International, Inc. today announced that the U.S. relaunch of ONSOLIS (fentanyl buccal soluble film) is being postponed until the product formulation can be modified to address two appearance issues raised by the U.S. Food and Drug Administration (FDA) following a recent inspection of the Aveva manufacturing facility where ONSOLIS is produced.

12 Mar 2012

USPTO rejects MonoSol's patent infringement claims against BDSI

The United States Patent & Trademark Office has informed BioDelivery Sciences International, Inc. that it has rejected all claims by MonoSol Rx, LLC (MonoSol) in its US Patent No. 7,425,292 (the '292 Patent) which is currently being asserted against BDSI and its commercial partners for ONSOLIS.

23 Feb 2012

Trevena commences TRV130 Phase I clinical trial for severe post-operative pain

Trevena, Inc., the leader in discovery and development of G-protein coupled receptor (GPCR) biased ligands, announced today the initiation of a Phase I clinical trial of TRV130, a novel candidate designed for the intravenous treatment of moderate-to-severe post-operative pain.

13 Feb 2012

Endo, BDSI partner to develop and commercialize BEMA Buprenorphine for chronic pain

BioDelivery Sciences International, Inc. today announced the signing of a worldwide license and development agreement with Endo Pharmaceuticals for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain.

6 Jan 2012

ProStrakan announces FDA approval for Transmucosal Immediate Release Fentanyl REMS Access program

ProStrakan, Inc., a subsidiary of Kyowa Hakko Kirin Co. Ltd., and an international specialty pharmaceutical company, today announces that the U.S. Food and Drug Administration has approved the TIRF (Transmucosal Immediate Release Fentanyl) REMS Access program.

31 Dec 2011

Single shared REMS for TIRF products receives FDA approval

The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system.

30 Dec 2011

Terrorist attacks with chemical weapons are a real possibility: Study

Terrorist attacks with chemical weapons are a real possibility, according to a study that appears in the online open access journal, Journal of Pharmacy Practice, published by SAGE.

12 Dec 2011

Impax initiates patent challenge related to Fentora

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Fentora® (fentanyl buccal tablets, 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg).

21 Nov 2011

Covidien fourth quarter net sales increase 15% to $3.08 billion

Covidien plc today reported results for the fourth quarter of fiscal 2011.

15 Nov 2011

J&JPRD submits NUCYNTA ER sNDA to FDA for DPN associated neuropathic pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for NUCYNTA ER (tapentadol) extended-release tablets, an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults.

31 Oct 2011

The Journal of Pain publishes results from Butrans Transdermal System Phase 3 clinical study

Butrans (Buprenorphine) Transdermal System CIII 20 mcg/hour provided significantly lower "average pain over the last 24 hours" scores compared to Butrans 5 mcg/hour when used in opioid-experienced patients with moderate-to-severe chronic low back pain, according to a pivotal Phase 3 clinical study published in the online, August issue of The Journal of Pain.

26 Sep 2011

Study: Opioid drugs can increase risk of pneumonia in older adults

Opioids -- a class of medicines commonly given for pain -- were associated with a higher risk of pneumonia in a study of 3,061 adults, aged 65 to 94, e-published in advance of publication in the Journal of the American Geriatrics Society.

23 Sep 2011

Drug overdose deaths surpass road traffic accident deaths in U.S.

According to newly released figures, drug-related deaths now outnumber traffic fatalities in the U.S., with the rise driven by an increase in prescription narcotic overdoses.

19 Sep 2011

Positive results from BDSI's BEMA Buprenorphine/Naloxone formulation Phase 1 study on opioid dependence

BioDelivery Sciences International, Inc. announced positive preliminary results from its Phase 1 study assessing the pharmacokinetics of a BEMA Buprenorphine/Naloxone formulation.

6 Sep 2011

BioAlliance Pharma announces oral communication of Livatag Phase II trial results on liver cancer

BioAlliance Pharma SA, a company dedicated to specialty and orphan oncology products, today announces oral communication of the Phase II clinical trial results of its orphan product Livatag at the annual congress of ILCA, the only international organization devoted exclusively to liver cancer research with participation of worldwide best specialists.

6 Sep 2011

New Pressurized Olfactory Device shows direct CNS effect of morphine

A simple new approach to nasal drug administration may allow morphine and other strong pain medications to be targeted directly to the central nervous system (CNS), reports an experimental study in the September issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

24 Aug 2011

Orexo reports net revenues of MSEK 55.2 for second quarter 2011

OREXO: STRONG SALES INCREASE FOR ABSTRAL. For the period. Royalty revenues from Abstral sales in Europe rose to MSEK 30.4.

10 Aug 2011

Akela announces new corporate focus on PharmaForm

Akela Pharma, Inc. today announced a new strategic focus on its profitable pharmaceutical contract manufacturing business, PharmaForm, LLC.

9 Aug 2011

Covidien third quarter net sales increase 14% to $2.93 billion

Covidien plc today reported results for the third quarter of fiscal 2011. Net sales of $2.93 billion increased 14% from the $2.56 billion reported in the third quarter a year ago.

26 Jul 2011

BDSI completes BEMA Buprenorphine Phase 3 trial on chronic pain

BioDelivery Sciences International, Inc. announced today that the last patient has completed the randomized portion of its Phase 3 clinical trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain, signifying completion of the trial.

25 Jul 2011