Draxis Health Inc. announced that the Therapeutic
Products Programme (TPP) of Health Canada has approved Permax®
(pergolide) for use as early therapy without levodopa in the treatment
of Parkinson's Disease (PD).
While Permax® had previously been indicated solely as an adjunct
to levodopa for the treatment of PD, it has now been shown to also
benefit patients when used alone (ie. monotherapy) in early stages of
Dr. Martin Barkin, President and CEO of Draxis Health stated, "We
are very pleased to report this new development regarding Permax®.
While levodopa is the main treatment for PD currently, its long term
use brings about serious side effects, such as motor fluctuations and
dyskinesias and, for this reason, the prescribing trend is to delay
commencing levodopa therapy as long as possible."
Dr. Barkin continued, "A new three-year, double blind study
presented at the 6th International Congress of Parkinson's Disease and
Movement Disorders compared the effects of pergolide monotherapy and
levodopa monotherapy. The results of this clinical trial, which
involved 294 previously untreated patients, demonstrated that
pergolide enhances patient functioning in all stages of PD and that
its early use, instead of levodopa, delays the onset of motor
fluctuations and dyskinesias. This represents a very positive
development for Canadians suffering from PD, especially those in the
early stages of the disease."
Draxis Pharmaceutica is the pharmaceutical division of Draxis
Health Inc. and is responsible for overseeing clinical trials,
regulatory approval, marketing, and sales of pharmaceutical products
in Canada. Focusing in neurology, Draxis markets Permax® and
Eldepryl® for Parkinson's disease, Alertec(TM) for narcolepsy as
well as a number of products in-licensed from Elan Corporation plc.
Draxis also holds the exclusive Canadian rights to Hectorol and for
Levulan® photodynamic therapy / photodetection for all indications.
During the past year, Draxis Pharmaceutica has launched Elan
products, Zanaflex® (tizanidine hydrochloride) and Diastat®
(diazepam rectal gel), into the Canadian marketplace and has assumed
marketing activities for a third product. Over the next few years a
number of additional Elan products will be launched in Canada. These
will include: Elan's Botulinum toxin type B injectable solution for
cervical dystonia, frovatriptan for the treatment of migraine, and
Ziconotide®, a novel N-type neuronal calcium channel blocker for the
treatment of chronic, intractable pain that recently was deemed
eligible for priority review by the TPP.