Is Rapastinel FDA approved?

Is Rapastinel FDA approved?

On January 29, 2016, Allergan (who acquired Naurex in July 2015) announced that rapastinel had received Breakthrough Therapy designation from the U.S. FDA for adjunctive treatment of major depressive disorder.

What are the new medications for depression?

The Food and Drug Administration (FDA) recently approved two new antidepressant medications that represent new approaches to treating depression: brexanolone and esketamine….Frequently prescribed SSRIs include:

  • Citalopram (Celexa)
  • Escitalopram (Lexapro)
  • Fluoxetine (Prozac)
  • Paroxetine (Paxil)
  • Sertraline (Zoloft)

What is AXS 05?

AXS-05 is a combination of bupropion and dextromethorphan and is an N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity.

Is there a fast acting antidepressant?

Ketamine, the best characterized rapid-acting antidepressant, marks a dramatic improvement over monoaminergic agents not only because of its speed of onset but because it relieves symptoms of depression even in patients who have not responded to other modalities, even including those who do not respond to …

Is AXS-05 FDA approved?

AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designations for MDD and for AD agitation.

Will AXS-05 be approved?

AXS-05 is not approved by the FDA. About Axsome Therapeutics, Inc. Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options.

Is rapastinel FDA approved for depression?

Rapastinel Approval Status. FDA Approved: No. Generic name: rapastinel. Previous Name: GLYX-13. Company: Naurex Inc. Treatment for: Depression, Major Depressive Disorder. Rapastinel (GLYX-13) is a novel NMDA receptor modulator in clinical development as an intravenous adjunctive therapy for major depressive disorder (MDD).

What is Breakthrough Therapy designation for rapastinel?

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to rapastinel, which follows the medication receiving a 2014 Fast Track Designation from the FDA. Rapastinel, an investigational medication for adjunctive treatment of major depressive disorder, is an intravenous drug that is a novel NMDA receptor agonist.

What is the difference between rapastinel and ketamine?

Ketamine is the NMDA receptor agonist that has made the topic of agents like rapastinel so exciting as potential treatments for a major depressive disorder. But ketamine comes with a number of side effects. The origin of rapastinel (formerly known as GLYX-13) is illustrated in the picture to the right…

Is rapastinel effective for treating trigeminal neuralgia?

Rapastinel may prove to be a viable treatment for TRD; it has the potential to produce a rapid antidepressant response without serious adverse events and improve functional symptoms. Areas covered: We review the efficacy of rapastinel via completed and on-going clinical trials.