Headache News and Research

Latest Headache News and Research

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Phase III trial demonstrates rapid efficacy of Zelrix in treating acute migraine

NuPathe Inc., a specialty pharmaceutical company developing innovative products for the treatment of neurological and psychiatric diseases, today announced data from the pivotal Phase III trial of Zelrix™, a novel transdermal patch in clinical development for the treatment of acute migraine. Zelrix combines NuPathe’s proprietary SmartRelief™ iontophoretic transdermal technology with sumatriptan, the most prescribed treatment for acute migraine in the United States.

10 Sep 2009

METOZOLV drug approved for treating gastroesophageal reflux disease

Wilmington Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV ODT (metoclopramide HCl), an orally disintegrating formulation of metoclopramide for the treatment of gastroesophageal reflux disease (GERD) and diabetic gastroparesis.

10 Sep 2009

GlaxoSmithKline's CERVARIX receives favorable recommendation from FDA Advisory Committee

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of CERVARIX((R)), the company's candidate cervical cancer vaccine (12-1 and 11-1, respectively).

10 Sep 2009

Merck's GARDASIL receives approval from FDA Advisory Committee

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

10 Sep 2009

FDA approves Salix' METOZOLV ODT for treating diabetic gastroparesis

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV™ ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. METOZOLV ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy1.

9 Sep 2009

Meda launches EDLUAR in the U.S.

Meda Pharmaceuticals Inc. (Meda) today announced the commercial availability of EDLUAR(TM) (zolpidem tartrate sublingual tablets) in the United States. EDLUAR is indicated for the short-term treatment of insomnia characterized by difficulties with falling asleep. EDLUAR is the first available under-the-tongue formulation of zolpidem tartrate, which is the most prescribed treatment for insomnia. Zolpidem tartrate is also the active ingredient in Ambien(R) oral tablets.

9 Sep 2009

FDA approves ISTA's Bepreve for treating ocular itch

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced the U.S. Food and Drug Administration (FDA) has approved Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.

9 Sep 2009

MRF announces winners of six 2009 research grants

The Migraine Research Foundation (MRF), the only nonprofit organization devoted solely to funding migraine research, today announced the winners of the 2009 research grants. This year's grantees will explore such important areas as pediatric migraine, the genetic association between migraine and cardiovascular events, and why opioids enhance migraine pain.

5 Sep 2009

Shire receives FDA approval for INTUNIV extended release tablets

Shire plc, the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

4 Sep 2009

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl).

4 Sep 2009

Shire's INTUNIV (Guanfacine) approved by the FDA for treatment of Attention-Deficit/Hyperactivity Disorder

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV- (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

4 Sep 2009

SAFLUTAN launched in United Kingdom and Spain

Merck Sharp & Dohme (MSD) has launched SAFLUTAN (tafluprost) in the United Kingdom and Spain, and additional launches in other countries are expected over the next several months, pending regulatory approvals, the Company said today.

3 Sep 2009

Biogen Idec's MS franchise to present at the 25th Congress of ECTRIMS

Biogen Idec today announced more than 70 platform and poster presentations from the company’s multiple sclerosis (MS) franchise being presented during the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany.

3 Sep 2009

Clinical trial results of sumatriptan published in a journal

NovaDel Pharma Inc. announced that an article titled “Rapid Oral Transmucosal Absorption of Sumatriptan, and Pharmacodynamics in Acute Migraine” was published online on June 22, 2009 in the peer-reviewed journal Headache: The Journal of Head and Face Pain.

3 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

CIF launches campaign by distributing a "Ten Tips "card to help parents easily identify potential life threatening injuries

As high school student-athletes begin the academic year and participate in double-day sports practices statewide, the California Interscholastic Federation is drawing attention to the health risks associated with concussions, heat stroke and dehydration.

3 Sep 2009

FDA approves Meda's ASTEPRO Nasal Spray

Meda Pharmaceuticals Inc. today announced that the US Food and Drug Administration (FDA) has approved ASTEPRO(R) (azelastine HCl) Nasal Spray 0.15%, for the treatment of the symptoms of seasonal and perennial allergic rhinitis (SAR and PAR). New ASTEPRO Nasal Spray 0.15% is the first nasal antihistamine to offer convenient once-daily dosing for patients who suffer from seasonal allergies.

2 Sep 2009

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009