Bupivacaine News and Research

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FDA extends Pacira's EXPAREL PDUFA goal date by three months

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for EXPAREL by three months.

14 Jun 2011

Positive results from EXPAREL Phase 3 study to be presented at ASCRS Annual Scientific Meeting

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that positive results from its Phase 3 study evaluating EXPAREL in patients following hemorrhoidectomy will be presented at the 2011 American Society of Colon and Rectal Surgeons Annual Scientific Meeting in Vancouver, British Columbia.

16 May 2011

Pacira Pharmaceuticals reports net loss of $9.8 million for first quarter 2011

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced financial results for the first quarter ended March 31, 2011, provided an update on the execution of its pre-commercial and launch strategies for EXPAREL, and reiterated 2011 financial guidance.

11 May 2011

Pacira to present EXPAREL data in postsurgical pain at two medical meetings

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that clinical and preclinical data highlighting the safety and efficacy of EXPAREL™ will be presented at two medical meetings.

6 May 2011

Top-line results from DURECT's ELADUR Phase II trial in chronic low back pain

DURECT Corporation announced today top-line results from a Phase II clinical trial in chronic low back pain for ELADUR, DURECT's proprietary investigational transdermal bupivacaine pain patch.

12 Apr 2011

Pacira reports net loss of $7.0 million for quarter ended December 31, 2010

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced financial results for the fourth quarter and full-year ended December 31, 2010, provided an update on the execution of its pre-commercial and launch strategies for EXPAREL and established 2011 financial guidance.

31 Mar 2011

U.S.-Chile collaborate to study new long-acting local anesthetic derived from algae

A U.S.-Chile collaboration is bringing surgical patients closer to having a long-acting local anesthetic. In a randomized, double-blind trial, patients given neosaxitoxin, a new local anesthetic derived from algae, had significantly less postoperative pain and recovered about two days sooner than those given the commonly used local anesthetic bupivacaine.

25 Feb 2011

Pacira prices initial public offering at $7.00 per share

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced the pricing of its initial public offering of 6,000,000 shares of its common stock at $7.00 per share, before underwriting discounts and commissions.

4 Feb 2011

Profectus BioSciences commences GENEVAX IL-12 phase 1 study for HIV

Profectus BioSciences, a leader in the development of therapeutic and preventive vaccines against infectious diseases and cancers, and the AIDS Clinical Trials Group announced today the initiation of a phase 1 study of Profectus' multi-antigen HIV plasmid DNA vaccine administered with various doses of GENEVAX™ interleukin-12 pDNA adjuvant and delivered using the electroporation based TriGrid™delivery system developed by Ichor Medical Systems.

6 Jan 2011

Biomet Biologics completes enrollment in Recover Kit clinical trial for chronic tennis elbow

Biomet, Inc., a global leader in the manufacture of orthopedic and biotechnology products, announced today that its subsidiary, Biomet Biologics, LLC, has completed the required 230 subject enrollment for its Recover® Kit clinical trial. This clinical trial studies the use of the Recover® Kit device, which produces autologous platelet-rich plasma (PRP) to treat chronic tennis elbow (lateral epicondylitis).

21 Dec 2010

Profectus' GENEVAX IL-12 pDNA adjuvant improves vaccine-induced response rate in Phase I HIV study

Profectus Biosciences, Inc., a leader in the development of therapeutic and preventive vaccines against infectious diseases and cancers, announced today that its GENEVAX™ IL-12 pDNA adjuvant has significantly improved the vaccine-induced response rate in a Phase I clinical study of an experimental DNA vaccine for the prevention of HIV infection.

15 Dec 2010

FDA accepts for filing Pacira's EXPAREL NDA for postsurgical pain management

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, announced today that the New Drug Application (NDA) for EXPAREL™, a long-acting bupivacaine for postsurgical pain management, has been accepted for filing by the U.S. Food and Drug Administration (FDA).

14 Dec 2010

Interleukin-1 plays major role in wound healing

Anesthesiologists are playing a leading role in research into the molecular factors affecting inflammation, pain, and healing of surgical incisions, as illustrated by papers published in the December issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

7 Dec 2010

Transforaminal injection of steroids is a viable alternative for lumbar radicular pain surgery

A recent study from Australian researchers determined that transforaminal injection of steroids was a viable alternative to surgery for lumbar radicular pain due to disc herniation. Full details of the study appear in the August issue of Pain Medicine, a journal published by Wiley-Blackwell on behalf of the American Academy of Pain Medicine, the Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists, and the International Spine Intervention Society.

30 Jul 2010

Innocoll submits SPA for phase 3 clinical trial of Cogenzia for adjuvant treatment of infected diabetic foot ulcers

Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Technologies Ltd., has submitted a Special Protocol Assessment (SPA) for a proposed phase 3 clinical trial to support the U.S. approval of Cogenzia™: Innocoll's topical antibiotic therapy for the adjuvant treatment of infected diabetic foot ulcers.

13 Jul 2010

DURECT reports European POSIDUR Phase IIb hysterectomy clinical trial results

DURECT Corporation announced today results from a European Phase IIb hysterectomy clinical trial conducted by Nycomed of POSIDUR™ (also known as SABER™-bupivacaine or Optesia™ in the E.U.), a proprietary product under development for the treatment of post-surgical pain.

17 Jun 2010

Hospira signs licensing agreement to develop and market DURECT's POSIDUR

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, and DURECT Corporation, a specialty pharmaceutical company, today announced that the companies have entered into a licensing agreement to develop and market DURECT's POSIDUR (SABER-bupivacaine) a long-acting version of the anesthetic bupivacaine currently in Phase III clinical trials.

8 Jun 2010

Pacira Pharmaceuticals receives $11.25M credit facility from GE Capital, Healthcare Financial Services

GE Capital, Healthcare Financial Services today announced it has provided an $11.25 million credit facility to Pacira Pharmaceuticals, Inc. The financing provides working capital, and facilitates advances toward regulatory approval and preparation for commercialization of Pacira's EXPAREL™ program.

12 May 2010

MAP Pharmaceuticals initiates PD trial comparing LEVADEX to IV DHE

MAP Pharmaceuticals, Inc. today announced that the Company initiated a pharmacodynamics (PD) trial to compare the acute effect of LEVADEX™ orally inhaled migraine therapy to intravenous dihydroergotamine mesylate (IV DHE) and placebo on pulmonary artery pressure as measured by echocardiography.

8 Apr 2010

King Pharmaceuticals commences Phase IIb clinical trial of ELADUR for chronic low back pain

DURECT Corporation announced today that its licensee, King Pharmaceuticals, has begun a Phase IIb clinical trial to evaluate ELADUR™ (TRANSDUR™-Bupivacaine) for the treatment of chronic low back pain. ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days from a single application.

7 Apr 2010