Insomnia News and Research

Latest Insomnia News and Research

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Cephalon, Inc. today announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL (armodafinil) Tablets [C-IV] and PROVIGIL (modafinil) Tablets [C-IV] have been approved by the U.S. Food and Drug Administration (FDA).

25 Oct 2010

Arena reports results of APD916 Phase 1 clinical trial for narcolepsy with cataplexy

Arena Pharmaceuticals, Inc. announced today results from a Phase 1 clinical trial of APD916, a novel drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy with cataplexy.

20 Oct 2010

Survey reveals impact of insomnia during menopause

Results released today from a survey of more than 900 women, who experienced sleep problems during menopause, shed light on the impact insomnia can have during this time in a woman's life. The survey also revealed that for many women, insomnia during menopause is not proactively addressed by their healthcare provider (HCP) and that often times, women don't communicate their symptoms to their HCP.

19 Oct 2010

Transcept announces Intermezzo tablet preliminary data for insomnia

Transcept Pharmaceuticals, Inc. today announced its preliminary analysis of data from the recently completed Intermezzo 3.5 mg (zolpidem tartrate sublingual tablet) highway driving study.

19 Oct 2010

Somaxon announces nonreceipt of Paragraph IV certification for generic Silenor ANDA

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that the website of the U.S. Food and Drug Administration (FDA) indicates that an Abbreviated New Drug Application (ANDA) for a generic version of Silenor® (doxepin) 3 mg and 6 mg was submitted on September 16, 2010.

19 Oct 2010

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.

18 Oct 2010

Studies explore impact of upper GI conditions on sleep

The impact of upper GI conditions, like gastroesophageal reflux disease (GERD) and functional dyspepsia, on sleep—and treatments aimed at providing relief to heartburn/acid reflux patients who suffer from disordered sleep—were explored in three new studies related to sleep dysfunction presented today at the American College of Gastroenterology's (ACG) 75th Annual Scientific meeting in San Antonio, Texas.

18 Oct 2010

Questcor's H.P. Acthar Gel sNDA for infantile spasms receives FDA approval

Questcor Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS), an ultra-rare orphan disorder affecting approximately 2,000 American children annually. IS is a devastating and potentially life-threatening form of epilepsy seen in infancy and early childhood.

15 Oct 2010

Acorda presents new analysis of AMPYRA tablets at ECTRIMS Congress

Acorda Therapeutics, Inc. today announced that a new analysis of AMPYRA (dalfampridine) Extended Release Tablets, 10 mg data examining walking improvement in treatment responders has been presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

15 Oct 2010

Study suggests treating RLS may improve sleep and quality of life in people with fibromyalgia

A study in the Oct. 15, 2010 issue of the Journal of Clinical Sleep Medicine found that adults with fibromyalgia had a much higher prevalence and risk of restless legs syndrome than healthy controls. The study suggests that treating RLS may improve sleep and quality of life in people with fibromyalgia.

15 Oct 2010

AGA's new book offers strategies to reduce IBS symptoms

A new book from the American Gastroenterological Association (AGA) offers patients with irritable bowel syndrome (IBS) a variety of strategies to lessen the burden that IBS puts on their everyday lives. IBS is a common disorder of the intestines that leads to crampy pain, gassiness, bloating and changes in bowel habits; there is no cure. The new book, "Master Your IBS," includes a variety of strategies to help patients learn how to manage their IBS symptoms and achieve greater freedom from IBS.

14 Oct 2010

Genmab and Lundbeck enter agreement to develop antibody therapeutics

Genmab A/S announced today an agreement to create and develop human antibody therapeutics for disorders of the central nervous system (CNS) with H. Lundbeck A/S. Genmab will create novel human antibodies to three targets identified by Lundbeck. Lundbeck will have access to Genmab's antibody creation and development capabilities, including its state of the art, fully automated pre-clinical antibody screening and characterization capabilities and its proprietary stabilized IgG4 and UniBody therapeutic antibody platforms.

13 Oct 2010

Alkermes' VIVITROL medication for treatment of opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL(naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence, following opioid detoxification.

13 Oct 2010

Twenty-two physical symptoms prevalent in all types of cancers

Twenty-two physical symptoms associated with cancer - symptoms often unrecognized and undertreated - are prevalent in all types of cancers regardless of whether the patient is newly diagnosed, undergoing treatment or is a cancer survivor, according to researchers from the Regenstrief Institute and the Indiana University schools of medicine and nursing.

12 Oct 2010

Lundbeck, Merck announce commercialization agreement for SYCREST sublingual tablets

H. Lundbeck A/S (Lundbeck) and Merck, known outside the United States and Canada as MSD, today announced a commercialization agreement for SYCREST (asenapine) sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck will pay an undisclosed fee as well as product supply payments in exchange for exclusive commercial rights to SYCREST in all markets outside the United States, China and Japan. Lundbeck expects to launch SYCREST in the European Union (EU), where it is already approved, at the beginning of 2011.

12 Oct 2010

Yoga decreases anxiety in childhood cancer patients and their parents

A new study reports that yoga can reduce the stress of cancer diagnosis and treatment experienced by childhood cancer patients and their parents. The findings were published in the September/October 2010 edition of Journal of Pediatric Oncology Nursing, published by the Association of Pediatric Hematology/Oncology Nurses (APHON).

11 Oct 2010

FDA warns of harmful stimulant in Slimming Beauty capsules

The U.S. Food and Drug Administration today advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions.

11 Oct 2010

Fisher Wallace Laboratories launches easy-to-use medical device for depression treatment

Fisher Wallace Laboratories today announced the launch of a bold YouTube video campaign that challenges the pharmaceutical drug industry and introduces the company's easy-to-use medical device prescribed for the self-treatment of depression: the Fisher Wallace Cranial Stimulator.

6 Oct 2010

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tapentadol extended release tablets.

4 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010