Allergan, a health care company, has received the US Food and Drug Administration (FDA) approval for its cell-based assay for use in the stability and potency testing of BOTOX (onabotulinumtoxinA) and BOTOX Cosmetic.
According to the company, the usage of the new assay will lead to the reduction of the use of animal-based assay testing for BOTOX and BOTOX Cosmetic by up to 95% or more over the next three years.
BOTOX is a prescription medicine that contains 21 different approved medical uses and is derived from purified botulinum toxin protein refined from the Clostridium botulinum.
BOTOX was first approved by the FDA 21 years ago, for the treatment of strabismus and blepharospasm, two eye muscle disorders.
In the US, BOTOX neurotoxin is also approved to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults, symptoms of severe underarm sweating (severe primary axillary hyperhidrosis).
Moreover, BOTOX Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity.
Allergan Research and Development CSO and executive vice president Scott Whitcup said they have achieved the scientific milestone in the development of an alternative test capable of eliminating the need for an animal-based assay for BOTOX.