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news.FDA has approved Allergan's Botox (onabotulinumtoxinA) for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity.
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Allergan said that Botox is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from Clostridium botulinum. Botox has a protected molecular structure that stabilizes the core toxin inBotox from degradation.
Botox can be injected into muscles to treat increased muscle stiffness in elbow, wrist, and finger muscles in adults with upper limb spasticity; to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults; to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older.
In clinical studies, the efficacy ofBotox persisted up to three months on average.Botox is the first and only neurotoxin approved by the FDA for the treatment of upper limb spasticity.
Allergan added that when injected at approved and labeled doses into a specific muscle or gland, Botox neurotoxin is expected to diffuse locally and expected to produce a safe and effective result by producing a localised and temporary reduction in the overacting muscle or gland, usually lasting up to approximately 3 to 6.7 months depending on the individual patient and indication. Specifically, the incidence of immunogenicity in patients treated withBotox for upper limb spasticity is 0.53%.
Mitchell Brin, senior vice president of global development and chief scientific officer of Botox at Allergan, said: “Upper limb spasticity can manifest weeks, months or even years after the original injury, possibly after a patient has stopped seeing a neurologist, physiatrist or their rehabilitation specialist, which is why it is severely undertreated and there’s a low awareness of the condition.
“The approval ofBotox marks another important evolution in medical care, as we look to raise greater recognition and understanding of upper limb spasticity among patients affected by the condition, and refer them to a neurologist or physiatrist to explore their various treatment options.”