Obstructive Sleep Apnea News and Research

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Obstructive sleep apnea (OSA) is a major heath problem. In the United States, at least 17 million people have moderate to severe OSA, which is characterized by heavy snoring, airway blockage and frequent awakenings during sleep.

VIVUS submits briefing document to FDA in effort to secure regulatory approval for QNEXA

VIVUS, Inc. today announced that the company, as part of its continuing effort to secure regulatory approval for QNEXA® in the U.S., submitted a briefing document to the Food and Drug Administration (FDA) designed to address items in the FDA's Complete Response Letter (CRL), issued on October 28, 2010. The company also announced that the Endocrine and Metabolic Division of the FDA has granted VIVUS a meeting in the second half of January 2011 to discuss the content of the proposed resubmission.

14 Dec 2010

VIVUS reports positive results from avanafil phase 3 study in erectile dysfunction

VIVUS, Inc. today announced positive results from TA-314, a phase 3 pivotal open-label safety study of avanafil, an investigational drug for the treatment of erectile dysfunction (ED). The study met all primary endpoints by demonstrating improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP2 and SEP3) and improvements in the International Index of Erectile Function (IIEF).

7 Dec 2010

FDA approves Inspire to begin STAR clinical trial to evaluate UAS therapy for OSA

Inspire Medical Systems, a leading developer of neuro-stimulation therapies for the treatment of obstructive sleep apnea (OSA), announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) to begin its STAR pivotal clinical trial. The STAR trial (Stimulation Therapy for Apnea Reduction), is a multi-center study that will evaluate both the safety and effectiveness of Inspire Upper Airway Stimulation (UAS) therapy in patients with moderate to severe obstructive sleep apnea (OSA).

30 Nov 2010

People with OSA are prone to develop atherosclerosis: Study

People with obstructive sleep apnea (OSA), a sleep disorder associated with obesity, have more non-calcified or "bad" plaque in their coronary arteries, according to a study presented today at the annual meeting of the Radiological Society of North America (RSNA).

30 Nov 2010

Tips to improve obese children's surgical outcomes and health

The American Society of Anesthesiologists (ASA) is taking action to educate parents about the increased risk of complications faced by obese children undergoing anesthesia. The number of obese children has doubled in the past two decades and tripled among adolescents and the ASA encourages parents to help improve both the surgical outcomes and long-term health of America's youth.

20 Nov 2010

Researchers find structural deficits in gray matter may be associated with daytime sleepiness

Patients with obstructive sleep apnea (OSA) may blame their daytime difficulties on simple sleepiness, but new research suggests that their brains may be to blame. Specifically, their cognitive challenges may be caused by structural deficits in gray matter, brought on by the intermittent oxygen deprivation that comes with OSA. The good news is that these deficits may be partially or fully reversible with early detection and treatment, according to Italian researchers

15 Nov 2010

VIVUS closes sale of MUSE business to Meda

VIVUS, Inc. today announced that it has closed the sale of its MUSE business to Meda. Under the purchase agreement, Meda acquired the MUSE assets including the United States and foreign MUSE patents, existing inventory and the manufacturing facility located in Lakewood, New Jersey.

8 Nov 2010

Endocrine Society unveils new guideline on endocrine and nutritional management of post-bariatric surgery patients

The Endocrine Society released a new clinical practice guideline for the nutritional and endocrine management of adults after bariatric surgery, including those with diabetes mellitus. The guideline features a series of evidence-based clinical recommendations developed by an expert task force. The guideline is published in the November 2010 issue of the Journal of Clinical Endocrinology & Metabolism (JCEM), a publication of The Endocrine Society.

4 Nov 2010

Most hospital patients at high risk for obstructive sleep apnea

Eighty-one percent of hospital patients are at high risk for obstructive sleep apnea, a Loyola University Health System study has found.

2 Nov 2010

Researchers analyze how sleep disorders affect risk perception in driving

Within the framework of a recent research project, University of Granada researchers will analyse how sleep disorders affect risk perception in driving. To such purpose, three last-generation simulators provided by the Faculty of Psychology will be employed.

29 Oct 2010

VIVUS receives FDA CRL for QNEXA NDA

VIVUS, Inc. announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA® (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

29 Oct 2010

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

Snoring may destroy grey matter

A new Australian study has found that snoring and troubled nights could be a warning of brain damage occurring while sleeping. The team looked at brain scans of 60 people, aged in their mid-40s and recently diagnosed with a common sleep disorder – obstructive sleep apnea. Obstructive sleep apnea often affects overweight and the obese and leads to snoring. Results showed “decreased amount of grey matter” when compared to healthy sleepers.

21 Oct 2010

STOP-BANG questionnaire on sleep apnea syndrome helps identify patients' risk for surgical complication

A research team from the Jefferson Sleep Disorders Center at Thomas Jefferson University Hospital has utilized a simple, eight-item pre-operative questionnaire about obstructive sleep apnea syndrome that could help identify patients at risk for complications following surgery, according to a report in the October issue of Archives of Otolaryngology-Head & Neck Surgery, one of the JAMA/Archives journals. Individuals prone to the obstructive sleep apnea syndrome as determined by the questionnaire appear to have an increased risk of heart, lung and other complications following elective surgery.

19 Oct 2010

Study reinforces need for physicians to screen obstructive sleep apnea prior to surgery

As Americans get heavier and heavier, the incidence of obstructive sleep apnea increases, and results from two clinical studies presented at ANESTHESIOLOGY 2010 reinforce the need for physicians to screen for the disorder prior to surgery in order to appropriately manage the patient in the operating room.

18 Oct 2010

ESH and ERS consent document to manage hypertension and OSA

Consensus document on the management of patients with obstructive sleep apnea and hypertension. Joint recommendations by The European COST Action B26, The European Society of Hypertension and The European Respiratory Society.

7 Oct 2010

Nasal CPAP machine may cause craniofacial changes

The use of a nasal continuous positive airway pressure (nCPAP) machine for more than 2 years may cause craniofacial changes in adults with obstructive sleep apnea (OSA).

5 Oct 2010

VIVUS announces divestiture of MUSE to Meda

VIVUS, Inc. today announced that it has entered into an asset purchase agreement with Meda - an international specialty pharma company - for MUSE®, transurethral alprostadil, for the treatment of erectile dysfunction (ED). Under the agreement, Meda will acquire the MUSE assets including the United States and foreign MUSE patents, existing inventory and the manufacturing facility located in Lakewood, New Jersey.

4 Oct 2010

Study examines link between insufficient sleep and blood pressure among pregnant women

A study in the Oct. 1 issue of the journal Sleep found that getting too little or too much sleep in early pregnancy is associated with elevated blood pressure in the third trimester. The study suggests that improving prenatal sleep hygiene may provide important health benefits.

1 Oct 2010

Adequate sleep is the secret to a long life

A new study, derived from novel sleep research conducted by University of California, San Diego researchers 14 years earlier, suggests that the secret to a long life may come with just enough sleep. Less than five hours a night is probably not enough; eight hours is probably too much.