Share this Post!

On 04 August 2023, the US Food and Drug Administration (US FDA) approved Zuranolone (Zurzuvae™), the first and only oral treatment for postpartum depression (PPD) in adults. PPD is a major depressive episode that usually occurs after childbirth but may also start during the later stages of the pregnancy. Prior to this approval by the US FDA, the accepted treatment for PPD was only available as an IV injection to be administered by a licensed healthcare professional in a healthcare facility.

A serious and potentially life-threatening condition, PPD is commonly characterized by sadness, guilt, and/or loss of interest in activities that one used to enjoy and a lessened ability to feel pleasure, and in some reported cases, having thoughts of harming themselves or their child. With that, there is a need to have a medication that is readily available and can be administered without the help of healthcare professionals.

The daily recommended dose for Zuranolone (Zurzuvae™) is 50mg and should be taken once a day, for 14 days, in the evening together with a fatty meal.

Currently, there is no ongoing application for product registration of Zuranolone with the FDA Philippines thru the Center for Drug Regulation and Research (CDRR). Likewise, no noted clinical trial protocol of the said product for postpartum treatment has been submitted to this Agency, to date. In addition to this, there has been no application for a Compassionate Special Permit (CSP) of the product from the CDRR as of the date of this press statement.

Should the Marketing Authorization Holder (MAH) of Zuranolone (Zurzuvae™) submits the necessary documents for application for product registration, it will undergo the usual evaluation process prior to approval.

Rest assured that the FDA Philippines remains dedicated to making novel medicines accessible to every Filipino.

#FDA #Educate #Regulate #Monitor