UK’s first oral treatment for postnatal depression approved by MHRA

Zuranolone has become the first oral treatment for postnatal depression (PND) to be approved for the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).

The drug, which carries the brand name Zurzuvae, can be used for the treatment of moderate to severe PND in adults following childbirth.

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Zuranolone is supplied as capsules and is taken at night with a fat-containing meal for 14 days. The most common adverse effects include memory impairment, confusion, drowsiness, dizziness, sedation, tremor, diarrhoea and fatigue.

Product information also carries warnings about suicidal behaviour, withdrawal reactions and sedative effects that can impair the ability to drive.

The MHRA advises that the drug’s sedative properties must be considered when prescribing to a new mother and that treatment should be initiated under the supervision of a specialist team in an appropriate setting.

The medicine may cause fetal harm and is contraindicated during pregnancy, so women should use effective contraception while taking zuranolone and for one week after completing the course.

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The MHRA said the medicine had undergone a rigorous assessment of safety, quality and efficacy. Marketing authorisation has been granted to Biogen.

Julian Beach, the MHRA’s interim executive director for healthcare quality and access, said: ‘The approval of zuranolone reflects our ongoing commitment to increasing access to new medicines that have the potential to make a real difference to people suffering from serious health issues.

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‘We are assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep the safety of zuranolone under close review.’