[WEB SITE] FDA OKs Botox for Adults With Upper Limb Spasticity

The US Food and Drug Administration (FDA) has approved an expanded indication for onabotulinum toxin A (Botox, Actavis) for the treatment of adults with upper limb spasticity, according to a company news release.

The expanded indication now adds two thumb muscles: the flexor pollicis longus, a forearm muscle that flexes the thumb, and the adductor pollicis, a hand muscle that adducts the thumb. The expanded indication increases the maximum dose from 360 to 400 units for the treatment of upper limb spasticity. The FDA also approved an increase to the maximum 3-month cumulative dose from 360 to 400 units in adults treated for one or more indications.

The drug is injected into affected muscles to relieve stiffness. It is unknown whether onabotulinum toxin A is safe or effective in treating upper limb muscles other than those in the elbow, wrist, and fingers or in treating spasticity in lower limb muscles.

“Debilitating Neurological Condition”

Onabotulinum toxin A is the first and only neurotoxin the FDA has approved for the treatment of upper limb spasticity. Upper limb spasticity is a debilitating neurological condition that causes muscle stiffness that can tighten muscles in the wrist, fingers, and thumbs.

More than 1.8 million Americans live with the disorder, which can occur weeks, months, or even years after a stroke.

“Simple tasks such as washing the affected hand or getting dressed can be limiting for patients with the condition, and they’re often left to depend on a caregiver to help them,” said lead clinical trial investigator Allison Brashear, MD, professor and chair, Department of Neurology, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, in the company statement.

“It’s important for patients experiencing these types of symptoms to talk to their doctor, who can refer them to a neurologist or physiatrist to discuss their treatment options,” she added.

The FDA approved onabotulinum toxin A to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults in March 2010. Spasticity often occurs after stroke, traumatic brain injury, or the progression of multiple sclerosis.

Studies Support Expanded Indication

The expanded indication follows a discussion of two additional randomized, multicenter, double-blind, placebo-controlled studies that evaluated the safety and efficacy of the drug in those with upper limb spasticity in thumb flexor muscle involvement, according to the company statement.

Continue —> FDA OKs Botox for Adults With Upper Limb Spasticity.

[WEB SITE] Ways to Treat Depression That Aren’t Antidepressants

Feb. 27, 2015 — There may be hope for hard-to-treat depression as scientists explore novel ways to help people who have the often crippling condition.

Recently, a number of studies have suggested the benefits of Botox, ketamine, and certain sometimes-unexpected means of treating depression.

“I’m excited in general, and I’m curious,” says Peter D. Kramer, MD, author of Listening to Prozac and Against Depression.

Each year, around 16 million U.S. adults battle major depression. Many of them benefit from antidepressants. But as many as a third get depressive symptoms despite medication. And side effects, which can include weight gain, nausea, and insomnia, are troublesome for some patients. That leaves many people with depression searching for alternatives.

But if Kramer is hopeful about the newer, novel ways to treat the condition, he’s also cautious. The studies backing those treatments aren’t conclusive, and none of the approaches have been approved by the FDA to treat depression (though some, such as ketamine, have been approved for other uses).

“Things are merely hopeful until they are demonstrated [safe and effective],” Kramer says. “It’s always hard to tell what’s going on, but it’s a very interesting time, and I think some of them will come through.”

Here’s a closer look at what might be used to help treat depression in years to come.

Ketamine. Already in use in certain clinics and in some emergency departments around the country, ketamine is an anesthetic most often used during surgery. It’s given through an IV, and it quickly eases symptoms of depression, often in a matter of hours. The benefit is temporary, though.

One recent study found it to be very good at helping curb suicidal thoughts in severely depressed people. But it’s expensive, still experimental as a depression treatment, and can cause hallucinations and other side effects.

“Some people are very uncomfortable with the side effects,” says Alan Manevitz, MD, a psychiatrist who specializes in treatment-resistant depression at Lenox Hill Hospital in New York City.

Nitrous oxide, or laughing gas. This is an anesthetic commonly used by dentists. A small study published last December reports that nitrous oxide improved depression symptoms within less than 2.5 hours.

Continue–> Ways to Treat Depression That Aren’t Antidepressants.