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Approval from the U.S. Food and Drug Administration (FDA) to market
Zanaflex- Tizanidine hydrochloride, the first new oral treatment for
muscle spasticity in the U.S. in more than 20 years. In the year
2006 the US Food and Drug Administration has approved safety
labeling revisions to advice against concurrent use of fluvoxamine
or ciprofloxacin in patients receiving Tizanidine HCl therapy. The
risk was more for serious cardiovascular events in patients with
serious heart problems receiving treatment with mixed salts of a
single-entity amphetamine product.
The potential for amphetamine therapy also worsen symptoms of
preexisting psychotic disorders. FDA approved safety labeling
changes for Tizanidine HCl (Zanaflex capsules and tablets, made by
Accorda Therapeutics, Inc) to warn against their concurrent use with
fluvoxamine or ciprofloxacin. The warning was based on data from
pharmacokinetic studies, showing that Tizanidine exposure following
a single 4-mg dose was significantly increased by concurrent
administration of either fluvoxamine or ciprofloxacin.
According to the FDA, the interaction between Tizanidine and these
drugs is likely because of their potent inhibition of the cytochrome
isoenzyme. Zanaflex is a treatment indicated for the management of
increased muscle tone associated with spasticity, a condition
affecting the central nervous system ("CNS") causing muscle
stiffness and rigidity. Spasticity can occur as a result of many CNS
disorders, particularly multiple sclerosis and spinal cord injury.
Upon review of the pivotal clinical studies and trials the FDA
recognizes that Zanaflex is safe and effective for the treatment of
a variety of patients who suffer from the debilitating symptoms of
spasticity," said Jan Wallace, M.D., Athena's vice president of
clinical and regulatory affairs. The pill was effective and the sale
of the drug by the manufacturer has been on a constant rise proving
them right, that this is the future when it comes to muscle
spasticity.
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