Those seeking the secret of eternal youth have long sought Botox to ease the cosmetic pain of wrinkles, but UK patients will soon be able to use the product to help with the more medically important issue of headaches.
The UK medicines regulator on Friday announced a world first with the decision to approve Botox for the prevention of severe migraine, in the latest extension of the growing medical as well as aesthetic uses of the drug produced by US-based Allergan.
The Medicines and Healthcare Regulatory Agency granted approval for its prescription in adults suffering from headaches for at least 15 days each month, of which at least eight days are with migraine, including sensitivity to light, nausea and numbness.
The move is a fresh boost for Allergan , which has long funded trials to extend the uses of Botox, derived from Clostridium botulinum, a bacterium that produces toxins which cause paralysis, and first approved for an application in the UK in 1994 with authorisation to treat facial spasm.
About half of the product’s annual $1.3bn sales are for cosmetic purposes, with the rest split between a range of conditions including post-stroke spasticity, twisted necks, cerebral palsy and excessive underarm sweating.
It is also being studied for overactive bladder.
The complex administration for migraine requires more than 30 injections into the neck muscles by specialist doctors during a consultation every three months, even assuming the National Health Service agrees to reimburse the drug.
The company estimated that there were 700,000 people who could benefit in the UK who suffered from chronic migraine, many of whom are already severely debilitated and see headache specialists and neurologists.
However, Allergan may yet face difficulties in selling the product unless or until the National Institute for Health and Clinical Excellence, the UK government’s medicines advisory body, considers whether it offers value for money.
A research note published earlier this month by Wells Fargo Securities forecast that with approvals in other European countries, the market across the EU for Botox to prevent migraine could be worth $200-300m a year.
It predicted substantially greater sales for the company in the US, if the Food & Drug Administration approves its use later this month, but put the probability at only 60 per cent.
The final-stage clinical trials funded by the company showed a significant reduction in migraines and headaches than those on placebo, although nearly 4 per cent withdrew from use of the drug.
Get alerts on Pharmaceuticals sector when a new story is published