FDA allowing new antidepressant on the market

New depression treatment

BIRMINGHAM, Ala. (WBRC) - For the first time in decades, the Food and Drug Administration (FDA) is allowing a new kind of antidepressant on the market.

UAB researchers helped get approval for this treatment, which is focused on helping the millions of Americans who do not respond to the classic antidepressants.

People in Alabama have very little access to this potentially game-changing medication.

“To find something that works would change everything,” a woman named Annie said.

Annie describes her life as gray. She is among the estimated one-third of antidepressant users considered treatment-resistant, meaning classic medications aren’t particularly helpful.

“I’ve tried Effexor, Wellbutrin, Paxil, Zoloft and some others,” said Annie. “Some have made me suicidal. Others give me weird side effects like my heart starts racing or I’ll have panic attacks.”

“The antidepressant medications available up to this point are really just variations on the medicines developed in the 1960’s,” explained Dr. Richard Shelton of UAB’s Department of Psychiatry and Behavioral Neurobiology. “If people don’t respond to one or two of [the classic medications] the likelihood of them responding [to others] is pretty low.”

At UAB, Shelton spent years looking at the potential effectiveness of a nasal spray using esketamine, a derivative of Ketamine. Ketamine is typically used as a sedative, and its properties effect the brain in different ways than standard antidepressants.

Clinical trials suggested the nasal spray version of esketamine could help treatment-resistant depression patients get significantly better. That nasal spray medication is now being manufactured by Janssen Pharmaceuticals as a drug called SpravatoTM. Even with FDA approval, there are still several hurdles to clear before this treatment is accessible in Alabama. “The treatment itself, the medication is very, very expensive, so most people are not going to be able to pay out of pocket,” said Shelton.

Health insurers in Alabama have only approved esketamine as a last resort for patients who fail other more invasive treatments, such as electric convulsive therapy. Patients who have tried those more rigorous therapies were purposely excluded from clinical trials, thus it’s unclear if the nasal spray will be as useful to them. The side effects of esketamine are not trivial either. Some could experience drowsiness or disassociation, making it necessary to administer the spray carefully and selectively.

“There are a lot of steps or stages that we have to take to get ourselves ready to provide this as a treatment, and we’re just not ready to do that yet at this point in time,” said Shelton.

As of now, esketamine is available only at specific clinics across the country. UAB’s Depression and Suicide Center expects to be one of those sites by the end of the year.

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