July 23,2014 News Release
Clinical trials are being undertaken of APL-130277, which is an easy-to-administer, fast
acting reformulation of the dopamine agonist apomorphine. Apomorphine is the only approved drug for “off” episodes. As many as half of all people with Parkinson's Disease have “off” episodes in which they have impaired movement or speaking capabilities.
Apomorphine is normally sold as Apokyn, which is injectable. For more information go to Apokyn : http://www.apokyn.com However, 85% of Apokyn patients have an injection site reaction due to apomorphine's acidity and so must continuously change the injection site.
APL-130277 contains a buffer that protects the patient from the acidic properties of Apokyn. CTH-105 is a Phase 2 clinical study of APL-130277.
APL-130277 will be studied in 16 people with Parkinson’s
disease who have not used apomorphine and who experienced at least one daily “off” episode, with a total duration of “off” in any 24-hour period of at least 2 hours. This open study will examine the effect of APL-130277 on relieving “off”
episodes over a single day, with dose-titration used to determine dose strengths necessary for future clinical use.
In particular, the dose strength information is necessary in order to conduct the larger CTH-300a efficacy study in apomorphine naive patients, which is expected to commence at the end of 2014. The primary means of assessment will be the change in the UPDRS III score, which is the most widely used Parkinson's Disease symptom questionnaire.
VIARTIS
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