Headache News and Research

Latest Headache News and Research

Second pivotal efficacy study not required for MAP Pharmaceuticals' LEVADEX NDA

MAP Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that a second pivotal efficacy study is not required for the Company's LEVADEX(TM) new drug application (NDA) submission for the acute treatment of migraine. The Company announced in May 2009 that the efficacy portion of its Phase 3 FREEDOM-301 clinical study of LEVADEX met all four primary endpoints. The Company had previously anticipated initiating a second pivotal efficacy study in the first quarter of 2010.

12 Jan 2010

Targacept signs collaboration and license agreement with AstraZeneca

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics™, today announced that its collaboration and license agreement with AstraZeneca for the global development and commercialization of TC-5214 for major depressive disorder (MDD) has become effective as a result of early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

11 Jan 2010

New data from phase 3 study of avanafil for treatment of ED announced

VIVUS, Inc. today announced new data from an analysis of the recently completed phase 3 study (REVIVE TA-301) of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED).

11 Jan 2010

BIDMC scientists identify new pathway to address the problem of photophobia during migraines

Ask anyone who suffers from migraine headaches what they do when they're having an attack, and you're likely to hear "go into a dark room." And although it's long been known that light makes migraines worse, the reason why has been unclear.

11 Jan 2010

Genentech's ACTEMRA approved to treat RA

Genentech, Inc., a wholly owned member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA® (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

8 Jan 2010

Sciele Pharma announces the U.S. availability of Adrenaclick

Sciele Pharma, Inc., a Shionogi company, today announced the U.S. availability of Adrenaclick™, a single-dose, epinephrine auto-injector for the emergency treatment for severe allergic reactions (Type I) such as anaphylaxis.

8 Jan 2010

Positive top-line results from Phase III study of aclidinium bromide announced

orest Laboratories, Inc. and Almirall, S.A. (ALM.MC) today announced positive top-line results from ACCORD COPD I, a three-month Phase III study comparing aclidinium 200µg and 400µg BID versus placebo.

7 Jan 2010

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Gilead Sciences, Inc. today announced that a Phase II clinical trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection met its primary objective.

7 Jan 2010

International Headache Society publishes new guidelines to stimulate more research on headache treatment

If you're one of the millions of headache sufferers around the world, more effective relief might be on the way in years to come. That's because the International Headache Society has just published new research guidelines intended to stimulate more research into headache treatment, and to provide researchers with guidelines to cut health risks associated with treatment.

6 Jan 2010

Sleep deficits in high school students may lead to depression, headache and poor performance

Only about 8 percent of high school students get enough sleep on an average school night, a large new study finds. The others are living with borderline-to-serious sleep deficits that could lead to daytime drowsiness, depression, headaches and poor performance at school.

6 Jan 2010

Health Canada approves Zyclara Cream for multiple actinic keratoses

Health Canada has approved Zyclara™ (imiquimod) Cream 3.75%, a topical prescription treatment for multiple actinic keratoses (AK) located on the face or balding scalp in adults. Actinic Keratosis is a common skin condition that can lead to squamous cell carcinoma, a form of non-melanoma skin cancer, if left untreated.

6 Jan 2010

IME introduces new drug-free pain relief alternative for headache

Innovative Medical Equipment, LLC. (IME) today announced the full U.S. market release of SOOTHEAWAY - a new, thermo-electrically heated and cooled therapy device that helps relieve migraine, tension or stress headache pain in the forehead, temples, occipital and ocular / sinus regions.

6 Jan 2010

Findings suggest abuse is a risk factor for chronic headache

Researchers from the American Headache Society's Women's Issues Section Research Consortium found that incidence of childhood maltreatment, especially emotional abuse and neglect, are prevalent in migraine patients.

5 Jan 2010

VELCADE sNDA receives FDA approval

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

5 Jan 2010

House Judiciary Committee calls for another hearing to assess football-related brain injuries

Chairman of the House Judiciary Committee John Conyers has called for another hearing on brain injuries in football to be held on Monday, January 4.

4 Jan 2010

ESS improves quality of life in CRS patients

Upwards of 76 percent of patients with chronic rhinosinusitis (CRS) experienced significant quality of life (QOL) improvements after undergoing endoscopic sinus surgery (ESS), according to new research in the January 2010 issue of Otolaryngology - Head and Neck Surgery.

3 Jan 2010

PHT comments on FDA's PRO Final Guidance

PHT Corporation, the leading provider of ePRO (electronic patient reported outcome) solutions used in more than 400 clinical trials worldwide, commented on the FDA’s recent release of a final guidance almost four years following a Draft Guidance on the topic. The Final Guidance is entitled: Guidance for Industry, Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims.

24 Dec 2009

Eli Lilly and Kowa Pharmaceuticals America to co-promote LIVALO in the U.S

Eli Lilly and Company (NYSE: LLY), Kowa Company, Limited, and Kowa's U.S. subsidiary, Kowa Pharmaceuticals America, Inc., today announced that Lilly and Kowa Pharmaceuticals America have entered into a co-promotion agreement in the United States to commercialize LIVALO® (pitavastatin). Lilly and Kowa have also entered into a licensing agreement in Latin America. LIVALO is a statin approved by the U.S. Food and Drug Administration (FDA) in August 2009 for the treatment of primary hyperlipidemia and mixed dyslipidemia.

24 Dec 2009

Senate rejects mass importation of medicine from Canada

In the midst of President Obama's push for health care reform, the Senate rejected a plan to allow American pharmacies and drug wholesalers to import federally approved drugs from abroad. That vote has proved to be a headache for customer service staff at companies like Canadameds.com (http://www.Canadameds.com), which sells low-cost prescription drugs directly to American consumers.

24 Dec 2009

Fluzone High-Dose inactivated influenza virus vaccine receives FDA approval

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

24 Dec 2009