Ai Jian announces the latest results of Cariprazine in the treatment of bipolar I depression April 04, 2018 Source: Sina Pharmaceutical On April 3, the world's leading pharmaceutical companies Allergan and Gedeon Richter announced good statistical results for the RGH-MD-53 trial, a phase 3 clinical study of cariprazine for the treatment of adults. Major depressive episodes associated with bipolar type I depression. In December 2017, in the study of the drug for bipolar I depression, the two companies announced good clinical results for the second key trial, RGH-MD-54. In this trial, cariprazine 1.5 mg and 3 mg were statistically superior to placebo (see: Erjian Kallikazine for the second critical phase III clinical success of bipolar I depression). In three key trials including RGH-MD-53, RGH-MD-54, and RGH-MD-56, the efficacy of cariprazine in the treatment of bipolar I depression was confirmed. Aijian plans to submit data from all three key trials of the company's Supplemental New Drug Application (sNDA) to the FDA in the second half of 2018. Cariprazine is currently approved in the United States under the brand name VRAYLAR® for the treatment of adult schizophrenia and acute treatment of mania or mixed seizures associated with bipolar I depression in adults. David Nicholson, chief development officer at Aerjian, said: "The results of the three key studies reinforce the support of cariprazine as a potential treatment for adult bipolar depression through data richness. Bipolar depression is often difficult to treat and may To make patients extremely debilitated. We are committed to developing some therapies to address the unmet needs of people with mental illness, and we are looking forward to submitting a sNDA application for cariprazine for patients with bipolar I depression." For the RGH-MD-53 trial, primary and critical secondary efficacy endpoints were achieved in the Cariprazine 1.5 mg dose group. Based on the main efficacy parameters Montgomery-Asberg Depression Rating Scale (MADRS) total score (p = 0.0417, LSMD-2.5), and key secondary parameters clinical overall impression-severity score (CGI-S) (p = 0.0417, LSMD - 0.3), the change from baseline to week 6 was significantly better in the Cariprazine 1.5 mg dose group than in the placebo group. In the primary parameters (p = 0.1051, LSMD -1.8) and secondary parameters (p = 0.1370, LSMD -0.2), the cariprazine 3 mg dose group improved numerically over the placebo group but did not reach statistical significance. . Dr. Gary Sachs, associate professor of psychiatry at Harvard Medical School, said, “Considering that there are few treatments currently used to treat these bipolar I-type depressive symptoms, treating bipolar depression can be very difficult. In addition, it can be used to treat various The number of products for bipolar depression (from mania to depression) is limited. These data are therefore very encouraging for patients and the wider psychiatric community because it shows the potential of cariprazine in the treatment of a full range of depression." In this study, 493 patients were randomized (1:1:1) to placebo, cariprazine 1.5 mg, and cariprazine 3 mg to assess the efficacy of cariprazine in patients with bipolar I depression. , safety and tolerability. Cariprazine is generally well tolerated in the trial. The overall incidence of adverse events was 51% in the 1.5 mg and 3 mg dose groups and 46% in the placebo group. Most adverse events were mild to moderate, and approximately 5% of patients who received cariprazine had to discontinue medication, compared with 3% in the placebo group. The most common adverse event in the Cariprazine group was the inability to sit still, irritate, nausea, and fatigue. Istvan Greiner, research director at Gedeon Richter, added, "Cariprazine is one of our flagship products, and today's good trial results further support its therapeutic value, making this promising treatment option a choice for patients with bipolar depression. "(Sina Pharmaceutical Compilation / Bernardo) Article Reference Source: Allergan and Richter Announce Positive Topline Results from Third of Three Pivotal Trials of Cariprazine in Bipolar I Depression Hidden Safe Box,Bedroom Safe Box,Intelligent Safe Box,Cash Box Hebei Yingbo Safe Boxes Co.,Ltd , https://www.ybsafebox.com
