UK regulators are the first in the world to issue the stamp of approval for the use of Allergan’s neurotoxin Botox as a preventive treatment for chronic migraine.

Specifically, the Medicines and Healthcare products Regulatory Agency has licensed the drug, which is most famous for its anti-wrinkle properties, for adults who have headaches for at least 15 days per month with migraine on at least eight of these days.

The approval is based on a clinical trial programme known as PREEMPT which showed that nearly 70% of patients treated with Botox (botulinum toxin type A) experienced a 50% reduction in migraine days, as well as a significant improvement in quality of life and headache-related disability scores compared with those given a placebo.

Moreover, the treatment was found to be generally well-tolerated in the study, with the majority of side effects mild to moderate and discontinuation rates low in both treatment arms - 3.8% in the patients receiving Botox and 1.2% in those given a placebo.

Welcoming the approval, Dr Andy Dowson, chairman of Migraine Action's Medical Advisory Board, said while he had been using Botox ‘off-label’ for migraine prevention for 10 years, “it is important that we now have the PREEMPT study results to confirm the impression from this clinical practice experience”.

“Botox will give many chronic migraineurs a new lease of life where individuals will be able to make more plans and not be so debilitated by their condition,” added Lee Tomkins, Director at Migraine Action.

One in seven people in the UK suffer from migraine, which costs the economy around £1 billion a year, highlighting the need for new and effective treatments - particularly prophylatic ones - to help combat the condition.

Botox is already a blockbuster pulling in annual revenues well over £1 billion, largely from its cosmetic use but also other medical conditions such as excessive sweating, and its official approval in chronic migraine should give sales a further boost given that it could benefit around 700,000 people in the UK alone.