Medical marijuana for insomnia! Zelira's product ztl-101 has achieved clinical success: good safety, significantly reducing the severity of insomnia!

February 20, 2020 / BIOON / -- zelira therapeutics is a global leading pharmaceutical marijuana company established by Australian marijuana preparation biopharmaceutics and private marijuana science company ilera therapeutics in October 2019 It is committed to developing brand marijuana products for the treatment of various medical diseases, including insomnia and autism Recently, the company released the positive results of phase Ib / IIA test to evaluate zlt-101 in the treatment of chronic insomnia The data showed that zlt-101 treatment achieved the main end point of statistically significant improvement in insomnia severity index score This is a randomized, double-blind, cross-over design phase Ib / IIA trial in which 24 patients with chronic insomnia aged 25-70 were enrolled The trial was designed to take ztl-101 for 14 nights and placebo for 14 nights with a washout period of one week All patients received a monitoring sensitivity test of the ztl-101 and placebo mixture before starting administration At the beginning of administration, each patient can be given a single dose (0.5ml / total cannabinoid 11.5mg) or a double dose (1ml / total cannabinoid 23mg) sublingually according to their symptoms Of the 23 patients who completed the protocol, 12 (52%) chose to increase ztl-101 from single dose (0.5ml / total cannabinoid 11.5mg) to double dose (1ml / total cannabinoid 23mg) (measured on the 14th night) 16 patients (69.5%) received double doses of placebo on the 14th night The primary end points of the study were: (1) drug safety based on adverse event reporting; and (2) insomnia symptoms measured by the insomnia severity index (ISI) at the end of the 14 night positive drug / placebo course The results were as follows: - primary endpoint 1: safe and well tolerated Thirty six non serious adverse events possibly related to ztl-101 were recorded in 17 patients The most frequently reported adverse events were dry mouth (22.2% of all events), followed by dizziness (16.7%), headache (11.1%) and sensory abnormality (11.1%) During the placebo period, 4 non serious adverse events were recorded in 4 patients Headache was the most common (50%), followed by dizziness (25%) and moodiness (25%) All adverse events were classified as mild and resolved shortly after waking up at night or daily (97.5%), or at the end of the trial ——Primary end point 2: ISI score improved significantly Compared with baseline ISI score (18.0 ± 3.7), ISI score (12.9 ± 5.3, P < 0.001) after ztl-101 treatment decreased significantly, while ISI score (18.0 ± 4.3, P > 0.05) after placebo treatment did not The ISI score of ztl-101 treatment and placebo treatment decreased by 5.2 ± 4.3 (confidence interval [CI] = 3.4-7.0]) and 0.0 ± 3.3 (confidence interval [CI] = - 1.8-1.9), respectively The difference of ISI between ztl-101 and placebo was statistically significant (P < 0.001) Professor Peter Eastwood, lead researcher of the study and director of the sleep science center at the University of Western Australia, commented: "This study represents the most rigorous clinical trial ever conducted to evaluate the therapeutic potential of medicinal marijuana in the treatment of chronic insomnia symptoms, and it is also the first clinical trial to use the insomnia severity index (which can be said to be the gold standard in this field) to measure the therapeutic effect of medicinal marijuana products on insomnia symptoms The fact that zlt-101 treatment has achieved a statistically significant improvement in ISI scores is impressive, especially considering the relatively short two-week administration time Given the safety of several approved treatments for insomnia, the lack of serious or sustained mild adverse reactions is also encouraging All in all, these results suggest that zlt-101 has the potential to be a new treatment for insomnia " Next, zelira therapeutics will provide the final report of this clinical trial by the end of March 2020, including an analysis of a set of secondary endpoints These results will provide reference for the design of clinical research in the future The company will also seek to deploy its unique launch, learn and development strategy in Australia, the United States, Germany, the United Kingdom and other regions where medicinal marijuana has been legalized In 2020, the company will rapidly commercialize the first clinically proven marijuana drug for insomnia to the global market, including the United States market It is estimated that 70 million people suffer from insomnia in the United States, and the market for prescription and over-the-counter drugs used to treat insomnia has an annual sales volume of more than $2 billion Zelira therapeutics is leading the development of clinically proven full spectrum cannabis drugs to enter the global insomnia drug market Original source: zelira therapeutics meets primary endpoints for phase (1B / 2a) medical cannabis trial for insomnia