LEARN MORE
IMAGE SOURCE: ©iStockphoto/ Botox Treatment/ author: Renphoto
|
Allergan points to late-stage clinical data that shows its popular wrinkle-eliminator, Botox, can be used for chronic migraines.
The announcement today had Allergan stock up nearly 13 percent.
Botox, or botulinum toxin type A, is the first therapy being investigated for chronic migraine treatment, the company says. Allergen says that patients receiving Botox experienced a significant decrease in headache days.
Phase III also showed the treatment was well tolerated.
Expect Allergan, based in Irvine, California, to apply for FDA approval to use Botox for chronic migraines by sometime next year.
An estimated 1.2 million to 3.6 million people suffer from chronic migraine headaches, according to Allergan.
Botox Cosmetic is approved to smooth wrinkles between the eyebrows, cervical dystonia, nerve and muscle spasms, and excessive armpit sweating.
Botox injections should not be given to people at the injection site or people sensitive to any ingredients in Botox. Heart and allergic reactions, such as difficulty swallowing, speaking, or breathing have been reported.
In January, Public Citizen, the nonprofit watchdog group, called for a black box warning on Botox.
Public Citizen did a safety analysis of Botox procedures from FDA records covering 1997 to 2006. Altogether, there were 658 adverse effects from injections.
Among those included potentially life-threatening pneumonia and fluid in the lungs and difficulty swallowing. There were also 16 deaths.
The data comes from drug manufacturers, so Public Citizen believes the numbers could be much higher.
In February, stock for the popular anti-wrinkle drug Botox took a plunge, dropping 5.6 percent, after the FDA warned that some children given the drug have died.
The children who died had the brain injury cerebral palsy and were given Botox, also known as botulinum toxin, to treat spasticity in their legs. #