(RxWiki News) The US Food and Drug Administration (FDA) approves a new medication to treat depression.
This medication is found under the brand name Auvelity which consists of dextromethorphan HBr and bupropion HCl.
In fact, it is the first of its kind in that it works on the N-methyl D-aspartate (NMDA) receptor.
Auvelity is approved to treat adults with major depressive disorder (MDD).
Available in extended-release tablets, it is to be taken twice a day, with or without food.
The starting dose is one tablet in the morning but then can be increased to twice a day after three days.
Since they are extended-release tablets, tablets need to be swallowed whole. Tablets can't be crushed, divided, or chewed.
“Auvelity represents the first new oral non-monoamine-based mechanism of action approved to treat major depressive disorder in over sixty years,” Maurizio Fava, M.D., psychiatrist-in-chief, department of Psychiatry, Massachusetts General Hospital, said in a press release.
According to Fava, the current antidepressants on the market do not work well for nearly two thirds of patients.
According to the manufacturer, this medication works quickly. During clinical trials, those treated with Auvelity saw some improvement in their depression symptoms starting at one week when compared to those taking the placebo.
Common side effects include diarrhea, dizziness, dry mouth, excessive sweating, headache, feeling very sleepy and sexual function problems.
This medication holds a boxed warning which is the most serious warning.
Just like with other antidepressants, there is an increased risk of suicidal thoughts and actions with this medication. There is a risk especially within the first few months of treatment or when the dose is changed.
This medication is not for everyone. If you have a seizure disorder or have or had an eating disorder, this medication is not recommended.
Furthermore, this medication can interact with several medications. It is important to tell your doctor about all the medications you are taking. This includes prescription, over-the-counter, herbal and nutritional supplements. Also, tell your doctor if you have recently stopped taking any medications. There are some medications that need to be out of your system before you start taking this one. Some of these include another type of antidepressant that belong to a class called monoamine oxidase inhibitors (MAOIs). Some examples include:
Auvelity is expected to be available in the US in the last quarter of this year.
This approval was granted to Axsome Therapeutics.
Speak to your health care provider if you have any questions.