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.
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 foetal harm and is contraindicated during pregnancy, so women should use effective contraception while taking zuranolone and for one week after completing the course.
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.
‘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.’
Note: A version of this story was first published by Pulse’s sister title The Pharmacist
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READERS' COMMENTS [1]
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Why did the MHRA base it’s decision on assurances that it met the regulatory standards (presumably from the manufacturer), instead of actually checking if it did or did not meet the standards for themselves, to make their decision? This smacks of an inadequate assessment by the regulator who just took the manufacturer’s word for it, believing them to have no conflict of interest – which is of course completely impossible!
What is it anyway this new drug? The name indicates that it is a steroid hormone.
It does not appear to be an antidepressant from any of the recognised usual groups, because it is licensed for a maximum of 14 days, and antidepressants tend to take rather longer than that to start to work.
Yet it has side effects that overlap between antidepressants and hypnotics, and there is reason to suspect it is highly addictive.
I think this will be something for only specialists to prescribe for a good while yet, whilst GPs gain experience in dealing with the inevitable demands from addicted patients for more of it after the specialist has issued the first supply : or will it be one of thise drugs that Psychiatrists will not write prescriptions for, but will be left for medically unqualified ‘perinatal’ staff to indicate GPs are negligent for not issuing prescriptions for it at their demand?