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UK women may be the first in the world to have access to a new non-hormonal treatment for hot flushes and night sweats caused by menopause, the Medicines and Healthcare products Regulatory Agency has said.

The MHRA announced yesterday (July 8) that it had become "the first regulator in the world" to approve elinzanetant, which is marketed as Lynkuet, for the treatment of moderate to severe vasomotor symptoms associated with menopause.

Lynkuet works by calming brain cells that become "overactive" when oestrogen levels drop and helping to "bring the body's temperature control back into balance," said the regulator. 

The drug, which is manufactured by Bayer, was the subject of an international randomised trial including over 1,400 women aged 40 to 65 that suggested a daily 120mg tablet was "significantly" better than placebo at reducing hot flushes and night sweats. 

Headache, fatigue and drowsiness are among the drug's most commonly reported side effects.

The MHRA's Julian Beach said the drug had met the watchdog's standards for safety, quality and efficacy, adding: "Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapoes.

"As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used."

NICE has not yet made any recommendation regarding making the drug available on the NHS.

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