BOTOX contender on the horizon
Taken from PARIS & SCOTTSDALE, Ari.–(BUSINESS WIRE)–March 17, 2008
Ipsen and Medicis announce submission of Reloxin BLA in aesthetics to the FDA
– Medicis and Ipsen today announced that Ipsen has submitted a Biologics License Application (“BLA”) for the botulinum toxin type A, Reloxin(1), in aesthetic indications (glabellar lines) to the U.S. Food and Drug Administration’s (“FDA”) Division of Dermatology and Dental Products, within the Center for Drug Evaluation and Research…
As of October 2007, Ipsen’s botulinum toxin type A is approved for aesthetic indications in 21 countries: Argentina, Australia, Belarus, Brazil, Columbia, Ecuador, Egypt, Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Slovak Republic, Ukraine, Uruguay, Venezuela, Vietnam, and Russia (in Russia, it is the first botulinum toxin type A approved in this field). Ipsen is also pursuing regulatory approval for medical indications for the product in certain additional key international markets.
Dysport is a neuromuscular blocking toxin which acts to block acetylcholine release, hence reducing muscular spasm and was initially developed for the treatment of motor disorders and various forms of muscular spasticity, including cervical dystonia (a chronic condition in which the neck is twisted or deviated), spasticity of the lower limbs (heal) in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial spasm. It was later developed for the treatment of a wide variety of neuromuscular disorders and aesthetic medicine. Dysport was originally launched in the United Kingdom in 1991 and has marketing authorisations in over 70 countries (at 31 December 2006). Ipsen has just recently filed a BLA for Dysport in cervical dystonia to the FDA.
Basically these two products work similarly, preventing transmission of muscle signals. There are differences in the pharmacological behavior of the two products, which allows for different companies to brand, distribtue, and market each product.
RELOXIN has been noted in scientific studies to work faster and longer than BOTOX. Patients treated with RELOXIN can anticipate seeing the effects 1-2 days after treatment while the effects of BOTOX typically takes about 5-6 days. Also, the effects of RELOXIN can last up to 4-6 months longer than BOTOX (BOTOX typically last for about 3 months).
What does this mean for you? Once RELOXIN is approved patients can expect a decrease in the price. (It seems that FDA approval for RELOXIN will take at least another 10 months from now.