Sunovion Pharmaceuticals recently announced the top line results for a key clinical phase 3 test.This clinical study, called cth-300, is a randomized, double-blind, placebo-controlled trial, designed to assess the effects of apomorphine sublingual, apomorphine sublingual, in the case of the Parkinson's disease, in the case of the motor, and the "OFF" of the "OFF". The cth-300 reached the primary endpoint and the critical secondary endpoint, and the drug was well tolerated.
Around the world, there are as many as 400-6 million Parkinson's patients. PD is a chronic progressive neurodegenerative disease. The main motor symptoms are tremor, stiffness, and movement impairment during rest, and non-motor symptoms include cognitive and mood disorders. It is the second most common neurodegenerative disease after alzheimer's disease, and the incidence of PD is increasing as the population ages. The OFF event of Parkinson's disease is the reappearance of PD symptoms, including motor and non-motor symptoms, in the case of drug control. OFF events may occur at any time of the day, usually after waking up in the morning and occurring periodically throughout the day. The characteristics of the OFF event are tremor, stiffness or slow movement, which can disturb the patient's ability to carry out daily activities, causing a heavy burden on patients, family members and caregivers. As many as 40 to 60 percent of PD patients develop OFF events, and their frequency and severity can deteriorate during the progression of the disease. These patients are in urgent need of a new drug to effectively control the onset of the OFF event.
The drug APL-130277, which ACTS as a dopamine agonist, is a fast-acting, easy-to-use drug that is used as a thin film under the tongue of a drug, apomine, to manage the OFF events associated with PD. Apopine is the only drug approved for use in patients with advanced PD to treat OFF events on demand, and is currently approved as a subcutaneous injection in the United States. The apomorphine hypoglossal membrane is designed to provide a simple and covert new solution that can be used in the morning and can be used up to five times a day.
The release results of CTH - 300 clinical phase 3 trials is a critical 12 weeks randomized, double-blind, placebo-controlled, parallel group study, to assess APL - 130277 in levodopa effectively, appear OFF the safety, efficacy and tolerability in PD patients. The study to the primary end point, in 109 patients with PD, according to preliminary results obtained in the MDS - unified Parkinson's disease assessment scale (MDS - UPDRS) ratings in the third part, in week 12, patients treated with APL - 130277 from drug to drug use after 30 minutes before the results statistically significant decrease compared with the placebo group, the effect continues until the last observation time point (90 minutes). In the 30 minutes after administration, the ratio of MDS-UPDRS in the drug group and the placebo group was 7.6 (p=0.0002). The exercise of PD patients was assessed using ms-updrs. The results showed that the study reached a critical secondary endpoint, that is, a higher remission rate (35% in the drug group and 16% in the placebo group) after the drug was administered.
Apomorphine hypoglossia has the potential to be used by Parkinson's patients to control the treatment of OFF events. It is well adapted, convenient and reliable, and it is expected to bring good news to more patients and family members.
Reference material "recent advances in research in the field of central nervous system diseases of | (phase 48)" February 6, 2018.