Analgesic Designed to Reduce Euphoric Effects of Abuse
Embeda™ (morphine sulfate and naltrexone hydrochloride [HCl]) Extended Release Capsules, the first U.S. Food and Drug Administration (FDA)-approved long-acting opioid designed to reduce drug liking and euphoria when tampered with by crushing or chewing, is now available in U.S. pharmacies in six dosage strengths: 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, and 100 mg/4 mg. Embeda, a long-acting Schedule II opioid analgesic, is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
The FDA approval was based on data from 12 clinical studies of Embeda, including Phase III data demonstrating efficacy and safety. In a Phase III study, Embeda provided significant pain relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee compared with placebo. In addition, an earlier Phase II study found Embeda was bioequivalent to another marketed extended-release morphine sulfate capsule product.
Embeda contains extended-release morphine pellets, each with an inner core of naltrexone HCl. If tampered with by crushing or chewing, the naltrexone HCl is released and absorbed with the morphine. Naltrexone reverses the subjective and analgesic effects of morphine by competitively binding to opioid receptors. However, the clinical significance of the degree of reduction in drug liking and euphoria reported in clinical studies has not yet been established. There is no evidence that the naltrexone component reduces the abuse liability of Embeda.
Source.“King Announces Commercial Availability of Embeda™.” (2009, September 21). Retrieved November 4, 2009, from http://www.reuters.com/article/pressRelease/idUS65943+21-Sep-2009+PRN20090921.
Cognitive Safety Established for Overactive Bladder Treatment
Findings presented at the International Continence Society’s annual meeting have demonstrated that Gelnique® (oxybutynin chloride) gel 10%—a topical gel indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency—is comparable to placebo in its effect on memory tests and other cognitive functions in older healthy adults when compared with immediate-release oral oxybutynin (OXB-IR) treatments. Oral oxybutynin was found to be associated with cognitive deficit in four previous trials.
In the double-blinded, double-placebo, Phase I study of 152 healthy older adults (mean age = 68) from five U.S. centers, participants were randomized to one of three treatment arms for 1 week of therapy: 1 g Gelnique once daily (Gelnique plus placebo OXB-IR capsule; n = 49); 5 mg oral OXB-IR three times daily (active OXB-IR capsules plus placebo Gelnique; n = 52); or placebo (placebo Gelnique plus placebo OXB-IR capsules; n = 51). After 1 week, participants were given a series of tests to assess cognitive and psychomotor functioning.
Results on the primary endpoint (Name-Face Association delayed recall) showed no significant treatment effect (p = 0.273), as well as no significant differences versus placebo (Gelnique versus placebo, p = 0.155; OXB-IR versus placebo, p = 0.177). However, on another sensitive test of delayed recall measuring participants’ ability to recall the location of misplaced objects in a simulated house, there was a significant difference between treatment groups (p = 0.029), with scores in the placebo and Gelnique groups both improving, and performance in the OXB-IR group declining.
No significant treatment-related group differences were found on the remaining tests of delayed recall and immediate recall. However, in an exploratory analysis of reliable change scores in the Hopkins Verbal Learning Test-Total Free Recall (i.e., a decline of at least 6 from the baseline score), 10 participants taking OXB-IR showed a significant decline, compared with 6 taking placebo and 5 using Gelnique. No significant treatment-related group differences were found on measures of psychomotor reaction time or for any of the Memory Assessment Clinics Self-Report Questionnaire variables.
Source.“New Data Suggest that Gelnique®(Oxybutynin Chloride) Gel 10% Does Not Impact Cognition Among Healthy Older Adults.” (2009, September 29). Retrieved November 3, 2009, from http://www.reuters.com/article/pressRelease/idUS104020+29-Sep-2009+PRN20090929.
Inhaled Medicine Approved to Treat Cardiopulmonary Disease
The U.S. Food and Drug Administration has approved Tyvaso™ (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH) using the Tyvaso Inhalation System, which includes the Optinebir device and accessories. Tyvaso is indicated to increase walk distance in patients with New York Heart Association Class III symptoms associated with World Health Organization Group I PAH, which includes multiple etiologies such as idiopathic and familial PAH, as well as PAH associated with scleroderma and congenital heart disease. Tyvaso contains the same active ingredient (treprostinil) as Remodulin® (treprostinil sodium) Injection, which is also approved for the treatment of PAH.
In the TRIUMPH-1 (TReprostinil sodium Inhalation Used in the Management of Pulmonary arterial Hypertension) randomized, double-blind, 12-week placebo-controlled clinical trial, patients taking Tyvaso in four daily inhalation sessions achieved a 20-meter improvement in 6-minute walk distance over those taking placebo (p < 0.0005). The safety and effectiveness in patients with underlying lung disease has not been established.
Source.“FDA Approves TYVASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension.” (2009, July 31). Retrieved November 3, 2009, from http://www.medicalnewstoday.com/articles/159403.php.
Oral Option Shows Promise for COPD
Daxas® (roflumilast), a once-a-day oral tablet, would be the first in an entirely new class of treatment for chronic obstructive pulmonary disease (COPD) if it receives approval from the U.S. Food and Drug Administration. Four Phase III trials of the phosphodiesterase 4 inhibitor, published in The Lancet, have shown that it improved lung function and reduced exacerbations in patients with moderate to severe COPD.
The two published 12-month studies demonstrated that roflumilast produced a statistically significant and clinically relevant reduction in exacerbations, even for patients who were also taking long-acting bronchodilators. The studies showed a reduction in moderate to severe exacerbations by 17% per patient per year. When added to standard bronchodilator therapies in the two 6-month studies, a clear trend for the reduction of exacerbations was observed with roflumilast, over and above what was achieved with these therapies alone.
Source.“Four Studies Published in The Lancet Show Roflumilast (Daxas®), a New Oral Approach to COPD, Improves Lung Function and Reduces Exacerbations.” (2009, August 27). Retrieved November 3, 2009, from http://www.medicalnewstoday.com/articles/162261.php.
Digital Diabetes Management Gets FDA OK
The Contour® USB meter, a blood glucose monitor that plugs directly into a computer providing users with instant access to information that can help optimize diabetes management, has been cleared by the U.S. Food and Drug Administration for marketing. The device connects directly to a computer and can store up to 2,000 test results. The built-in USB technology allows patients to review their results with their physician during office visits, over the telephone, or via e-mail, giving them the opportunity to make treatment adjustments.
The Contour USB meter features:
- A bright color display screen visible in any light that shows average, high, and low readings.
- Customizable features such as intuitive pre- and post-meal marking.
- 500MB extra memory for storage of personal diabetes information.
- Rechargeable battery that can charge from any USB port or via the wall charger provided.
- Glucofacts™ Deluxe software for easy retrieval of data as well as longer-term tracking and analysis of blood glucose test results.
For more information, visit http://www.BayerContourUSB.com.
Source.“Bayer Introduces Contour USB—The First Blood Glucose Meter with Unique Plug & Play Diabetes Management Software.” (2009, September 21). Retrieved November 3, 2009, from http://www.medicalnewstoday.com/articles/164668.php.