Insomnia News and Research

Latest Insomnia News and Research

J&JPRD submits an NDA for tapentadol ER tablets

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol extended release (ER) tablets, an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older.

2 Dec 2009

Amgen to present updated data on Nplate at the 2009 ASH meeting

Amgen Inc. today announced that it will present updated long-term safety and efficacy data for Nplate® (romiplostim) in adult chronic immune (idiopathic) thrombocytopenic purpura (ITP). Additionally, Amgen will present the first Nplate study in a pediatric setting as well as in patients with myelodysplastic syndromes (MDS) at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition (Dec. 5 - 8, 2009).

1 Dec 2009

Transcept Pharmaceuticals to discuss the Complete Response Letter for Intermezzo NDA

Transcept Pharmaceuticals, Inc. today announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, 2009, indicated that the FDA could not approve the NDA in its present form.

24 Nov 2009

FDA approves sNDA for pediatric autism drug ABILIFY

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

20 Nov 2009

Millennium commences Phase I clinical trial for its second-generation proteasome inhibitor

Millennium: The Takeda Oncology Company today announced it has further expanded its protein homeostasis program with the initiation of a Phase I clinical trial for an oral formulation of MLN9708, the Company’s second-generation proteasome inhibitor. An intravenous formulation of MLN9708 entered clinical trials in March.

18 Nov 2009

Shire publishes new study results on INTUNIV Extended-Release Tablets

Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone.

17 Nov 2009

Results of Phase III clinical trials of flibanserin for treatment of HSDD in pre-menopausal women released

Data from pivotal Phase III clinical trials demonstrate that flibanserin 100mg increased the number of satisfying sexual events (SSE) and sexual desire (the co-primary endpoints) while decreasing the distress associated with Hypoactive Sexual Desire Disorder (HSDD).

16 Nov 2009

ECR Pharmaceuticals to commercialize and manufacture ZolpiMist in the U.S. and Canada

NovaDel Pharma Inc. today announced its entry into an exclusive license and distribution agreement with ECR Pharmaceuticals Company, Inc., a wholly owned subsidiary of Hi-Tech Pharmacal Co., Inc. to commercialize and manufacture ZolpiMist™ in the United States and Canada. ZolpiMist™ is our oral spray formulation of zolpidem tartrate approved by the FDA in December of 2008.

16 Nov 2009

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Alkermes, Inc. today announced positive preliminary results from a phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002).

16 Nov 2009

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse-. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

16 Nov 2009

Shire announces findings from Phase 3 study data with Vyvanse

Shire plc, the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

13 Nov 2009

Transcept Pharmaceuticals reports financial results for the third quarter of 2009

Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience, today announced financial results for the three and nine months ended September 30, 2009.

13 Nov 2009

Mental Health America and Prescription Audio team up to provide free sound therapy

Mental Health America today announced it is partnering with Prescription Audio, a Philadelphia-area based firm (Voorhees, N.J.), to make the company's scientifically based sound therapy available without charge as a download to veterans, active duty servicemen and women, their family members and health care providers.

12 Nov 2009

Potential benefits of Labopharm's novel trazodone formulation published

Labopharm Inc. today announced an article has been published in the international journal of neuropsychiatric medicine, CNS Spectrums October, 2009 issue, citing the potential benefit of its novel trazodone formulation, which contains Contramid(R). Labopharm's Contramid is the clinically validated proprietary technology that controls the release of active substances from oral medications to optimize drug delivery.

11 Nov 2009

Computerized alerts induce clinicians to prescribe comparable generic equivalents

Simple computerized alerts can help curb the impulse to prescribe unnecessarily expensive, heavily marketed drugs. A study in the August issue of Journal of General Internal Medicine found that when clinicians received computerized alerts, which compared medication brands, they changed 23.3 percent of prescriptions for four heavily marketed sleep medications to comparable generic equivalents.

10 Nov 2009

USPTO issues Notice of Allowance to NovaDel Pharma

NovaDel Pharma Inc., today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. Patent Application No. 10/671,715, entitled “Buccal, Polar and Non-polar Spray Containing Zolpidem,” which covers a method of treating insomnia by administering zolpidem to humans utilizing NovaMist™ Oral Spray spray technology.

6 Nov 2009

CHANTIX/CHAMPIX raises hope for quitting smoking

New study results showed that 42.3 percent of smokers with mild-to-moderate chronic obstructive pulmonary disease (COPD) who took CHANTIX/CHAMPIX® (varenicline) were able to quit smoking and remain abstinent during the last four weeks of treatment (weeks 9-12) compared with 8.8 percent of those given placebo (p<0.0001). These findings were presented by investigators at CHEST 2009, the 75th annual international scientific assembly of the American College of Chest Physicians (ACCP).

5 Nov 2009

Green tea holds hope for prevention of oral cancer

Green tea extract has shown promise as cancer prevention agent for oral cancer in patients with a pre-malignant condition known as oral leukoplakia, according to researchers at The University of Texas M. D. Anderson Cancer Center.

5 Nov 2009

Green tea extract shows promise as cancer prevention agent for oral cancer, reveal researchers

5 Nov 2009

Takeda Pharmaceuticals strengthens its North American market

Takeda Pharmaceuticals North America, Inc., today announced the incorporation of Takeda Pharmaceuticals Mexico, S.A. de C.V. This expansion strengthens the company's North American presence, bolstering existing operations in the United States and Canada. Takeda Pharmaceuticals Mexico will be headquartered in Mexico City.

4 Nov 2009

Insomnia News and Research

Latest Insomnia News and Research

J&JPRD submits an NDA for tapentadol ER tablets

Amgen to present updated data on Nplate at the 2009 ASH meeting

Transcept Pharmaceuticals to discuss the Complete Response Letter for Intermezzo NDA

FDA approves sNDA for pediatric autism drug ABILIFY

Millennium commences Phase I clinical trial for its second-generation proteasome inhibitor

Shire publishes new study results on INTUNIV Extended-Release Tablets

Results of Phase III clinical trials of flibanserin for treatment of HSDD in pre-menopausal women released

ECR Pharmaceuticals to commercialize and manufacture ZolpiMist in the U.S. and Canada

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

Shire announces findings from Phase 3 study data with Vyvanse

Transcept Pharmaceuticals reports financial results for the third quarter of 2009

Mental Health America and Prescription Audio team up to provide free sound therapy

Potential benefits of Labopharm's novel trazodone formulation published

Computerized alerts induce clinicians to prescribe comparable generic equivalents

USPTO issues Notice of Allowance to NovaDel Pharma

CHANTIX/CHAMPIX raises hope for quitting smoking

Green tea holds hope for prevention of oral cancer

Green tea extract shows promise as cancer prevention agent for oral cancer, reveal researchers

Takeda Pharmaceuticals strengthens its North American market

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

Insomnia News and Research

Latest Insomnia News and Research

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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