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Zuranolone MHRA Approval: Postnatal Depression Treatment

by Dr. Michael Lee – Health Editor

New Treatment Option for Postnatal Depression Faces UK⁤ Access hurdles

A new ​medication, zuranolone, has received approval from teh Medicines and Healthcare products⁣ Regulatory Agency (MHRA) in ​August 2025 for the treatment of moderate to severe postnatal​ depression (PND) in adults. This marks a potential⁤ turning point,⁤ as currently no medications in the UK are specifically licensed for perinatal mental health conditions.

Zuranolone is a synthetic form of allopregnanolone, a neuroactive steroid naturally produced in the body.Allopregnanolone levels ⁣fluctuate dramatically during and after pregnancy, with a sharp decline post-delivery potentially contributing to the growth of PND in⁣ some women.

Unlike conventional antidepressants that require weeks of consistent use to demonstrate effect, zuranolone is administered as a 14-day course, with ​some patients reporting improvements within three ​days. This rapid action offers a potentially significant benefit⁢ for women experiencing severe distress.

However, access to zuranolone in ⁢the ‌UK is currently uncertain. While approved by the MHRA, the National Institute for Health and Care ‌Excellence (NICE) is evaluating its cost-effectiveness. In draft guidance released in August 2025, NICE currently does not recommend routine use of the drug, primarily due to its high cost – a course currently priced around‌ US$16,000⁤ in the‍ United States – and limited data⁤ on⁤ the⁣ long-term duration of its benefits, as studies to date have followed patients for relatively short periods. A final decision from NICE is anticipated in October 2025.

Further considerations⁤ surround the ⁢use of zuranolone while breastfeeding.Preliminary data⁤ suggest minimal transfer into breast milk, but ​the evidence base remains limited, and some experts recommend temporarily pausing breastfeeding during treatment.

Despite these hurdles, the potential of zuranolone is significant. Suicide remains a leading cause of maternal death in the UK, and rapid-acting treatments could provide crucial support for women in crisis.⁤

Pharmacists are poised to play a vital ⁣role in the potential implementation of zuranolone. They are often well-positioned to identify early ⁣signs of PND and anxiety, offer non-judgmental support, and​ connect women ⁣and families with appropriate local resources. Should zuranolone​ become ‌available, pharmacists⁢ will be key​ in⁢ educating patients about its mechanism, expected benefits and side effects, and its compatibility with breastfeeding and​ other medications. Crucially,they can also contribute to destigmatizing perinatal mental ⁤health by fostering ​open and routine conversations.James Lee,lead pharmacist,specialist community ‌perinatal mental health service,Devon Partnership NHS Trust

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