U.S. FDA approves drug to treat rare form of cystic fibrosis

Posted by: Doctor Medical  :  Category: Health News

WASHINGTON (Xinhua) – The U.S. Food and Drug Administration (FDA) approved Kalydeco for the treatment of a rare form of cystic fibrosis in patients aged six years and older who have the specific G551D mutation in the CFTR gene.
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Keppra XR Dosage Strength Tablets to Combat Partial One-Set Seizures

Posted by: Doctor Medical  :  Category: Health, Health News, Medication

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Keppra has improved on its dosage, unveiling the Once-daily Keppra XR extended-release tablets which are now available in a new dosage strength, 750 mg. This enables doctors to simplify patients’ treatment plans by decreasing the number of tablets they take each day.

According to studies published in Epilepsy & Behavior and Neurology, patients are more likely to adhere to their medication regimen when it is taken once daily, and therefore may be more likely to reach the goal of epilepsy therapy–seizure freedom with minimal side effects.

Keppra XR was approved by the U.S. Food and Drug Administration (FDA) based on data from an international clinical study of 158 epilepsy patients with partial-onset seizures who added 1,000 mg of Keppra XR or placebo to their other epilepsy medications once daily. The study consisted of an 8-week baseline period followed by a 12-week treatment period.

  • The study showed that 10.1 percent of Keppra XR(TM) patients experienced complete partial-onset seizure freedom vs. 1.3 percent in the placebo group over the treatment period.
  • Keppra XR patients experienced a 46.1 median percent reduction in weekly partial-onset seizure frequency versus 33.4 percent in the placebo group.

Keppra XR is also available in 500 mg tablet strength. Data presented at last year’s American Epilepsy Society meeting demonstrated that taking two 750 mg levetiracetam extended-release tablets is the same as taking three 500 mg extended-release tablets.

Treatment with Keppra XR should be initiated with a dose of 1,000 mg once daily. The daily dosage may be adjusted in increments of 1,000 mg every two weeks, to a maximum recommended dose of 3,000 mg per day.

(Source) Press

How Nanosized Particles May Affect Skin Care Products

Posted by: Doctor Medical  :  Category: Health News, Medical Gadgets, Technology

The rapidly growing field of nanotechnology and its future use in cosmetic products holds both enormous potential and potential concern for consumers. Currently, major cosmetic manufacturers have imposed a voluntary ban on the use of nanoparticles in products while they await a ruling from the Food and Drug Administration (FDA) regarding the safety of this technology. However, these manufacturers know that when ingredients in products such as sunscreens and anti-aging products are converted into nanosized particles, the end product displays unique properties that can benefit the skin in ways that otherwise could not be achieved using larger-sized particles.

Speaking today at the 68th Annual Meeting of the American Academy of Dermatology (Academy), dermatologist Adnan Nasir, MD, PhD, FAAD, clinical assistant professor in the department of dermatology at the University of North Carolina in Chapel Hill, presented an overview of nanotechnology and how nanoparticles may eventually be used in cosmetic products.

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FDA Approves EMBEDA For Management of Moderate to Severe Chronic Pain

Posted by: Doctor Medical  :  Category: Health, Health News, Medication

King Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. EMBEDA is the first FDA-approved long-acting opioid that is designed to reduce drug liking and euphoria when tampered with by crushing or chewing.

Utilizing King’s proprietary technology, EMBEDA contains extended-release morphine pellets, each with an inner core of naltrexone hydrochloride, an opioid receptor antagonist. If taken as directed, the morphine relieves pain while the sequestered naltrexone hydrochloride passes through the body with no intended clinical effect. If EMBEDA is crushed or chewed, the naltrexone is released and absorbed with the morphine, reversing the morphine’s subjective and analgesic effects. The clinical significance of the degree of this reduction has not been established, and there is no evidence that the naltrexone in EMBEDA reduces the abuse liability of EMBEDA.

Press