PHARMACY

FDA approves Belviq XR from Eisai, Arena

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration has approved Eisai’s and Arena Pharmaceuticals’ Belviq XR (lorcaserin HCl) extended-release 20-mg tablets, the companies announced Tuesday. 
 
The drug is a new formulation of lorcaserin that can offer patients once-daily dosing and could help maintain weight loss, as it’s indicated for use in patients for chronic weight management. Following the approval, Arena will receive a $10 million milestone payment. 
 
"With approximately two-thirds of the U.S. population living with extra weight or obesity, there is a significant and growing need to address chronic weight management," said Dr. Louis J. Aronne, M.D., principal investigator of the Belviq clinical trials. "Having a once-daily treatment may offer an option for patients to stay on track to meet their weight loss goals."
 
The companies expect Belviq XR to be available in the fall of 2016. 
 
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Ajanta launches generic Axert

BY DSN STAFF
BRIDGEWATER, N.J. — Ajanta Pharma USA on Tuesday announced the launch of its generic Axert (almotriptan malate) tablets. The drug is indicated for acute treatment of migraine headaches in patients with a history of migraine with or without aura. 
 
Ajanta’s almotriptan malate tablets will be available in 6.25- and 12.5-mg dosage strength. 
 
 
 
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Cefaly Technology relaunches Rx-only migraine wearable

BY Michael Johnsen

NEW YORK – Cefaly Technology on Monday relanuched its "wearable" for the treatment of migraines after undergoing a massive makeover, the company announced.

Cefaly I, which gained popularity for its unique headband-like shape, is now three-quarters its size, fits in the palm of a person's hand, is rechargeable, uses magnets to stay in place and allows patients more control over the intensity of their daily session. The new Cefaly II, is available exclusively in the United States; it will become available next in Europe in September.

"This compact device is so easy to tuck in a pocket or purse and I am hopeful it will further increase compliance and bring an even larger reduction in migraine attacks to patients," stated Pierre Rigaux, CEO Cefaly Technology.  "Cefaly I has a tremendous success record. In clinical trials 81% of compliant patients showed a significant reduction in migraine attacks and up to a 75% reduction in consumption of migraine medications. Now that the device is so small, it's a big deal because patients can have their Cefaly II with them wherever they go, which means they'll be able to use it more readily, at their most convenient time."

Cefaly is an electronic, battery-powered, device that is placed on the forehead for 20-minutes once a day, using a self-adhesive electrode and a magnetic connection. The device sends tiny electrical impulses through the skin to desensitize the upper branches of the trigeminal nerve and reduce the frequency of migraine attacks. The new device allows patients to control their session by ramping up the intensity to their desired comfort level. Also, the introduction of a magnetic connection means the device will more quickly fall into place  – and more securely maintain its connection – rather than be affixed to a fastener where a small movement could occasionally interrupt the session.

Also new is a built-in rechargeable Lithium-ion Polymer 3.7 V battery that replaces the two AAA batteries, which contributed to the device's shape and bulk. The new battery allows for the Cefaly II to be charged either by a USB cable on a home or work computer, or through a wall charger.

The new pocket-sized Cefaly II device includes a USB cable, wall charger, a storage case and one electrode. The device costs $349 and comes with a 60-day money back guarantee.

A pack of three electrodes costs $25; each electrode may be re-used up to 20 times.

Cefaly II is available by prescription-only and indicated for patients 18 years of age and older. Women who are pregnant or could become pregnant should check with their doctor before using Cefaly. In clinical trials, only 4.3% of people reported side effects – all of which were minor and fully reversible.

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