BioXcel Therapeutics' Approved Drug For Bipolar Disorders/Schizophrenia Shows No Evidence Of Worsening Or Withdrawal In Post-Marketing Study
BioXcel Therapeutics' Approved Drug For Bipolar Disorders/Schizophrenia Shows No Evidence Of Worsening Or Withdrawal In Post-Marketing Study
Tuesday, BioXcel Therapeutics Inc (NASDAQ:BTAI) released topline results from a post-marketing requirement (PMR) study of Igalmi (dexmedetomidine) sublingual film that demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with the 180 mcg dose after seven days of PRN (as-needed) treatment.
BioXcel Therapeutics Inc (納斯達克:BTAI)在週二發佈了Igalmi（右旋美託咪啶）舌下膜的一項發售後研究（PMR）的頭號結果，證明在PRN（按需）治療7天后使用180毫克劑量無論是速效性、耐藥性或戒斷現象均無證據。
In the single-arm, open-label study, 28 inpatient adults with frequent episodes of agitation associated with bipolar disorders or schizophrenia self-administered 180 mcg dose of Igalmi as needed over seven days. A total of 83 episodes were treated.
在這項單臂、開放標籤的研究中，28名住院病人以自我管理方式在7天內使用180毫克Igalmi。共治療了83次病症。
Although the study was not statistically powered to evaluate repeat-dose efficacy, changes in agitation were assessed through the Positive and Negative Syndrome Scale-Excitatory Component (PEC or PANSS-EC) Score and the Clinical Global Impressions – Improvement (CGI-I) Scale, the same measures as used in previous Phase 3 studies.
儘管該研究不具備統計學能力來評估重複劑量療效，但通過評估陽性和陰性綜合徵量表 - 刺激性成分（PEC或PANSS-EC）評分和臨床整體印象 - 改善（CGI-I）評分來評估激動的變化，這與之前第III期研究中使用的評估方法相同。
Mean PEC score reduction was observed following all doses of Igalmi administered as needed over the treatment period.
在治療期間使用所有需要的Igalmi劑量後，觀察到平均PEC評分降低。
All patients showed improvement in agitation symptoms for all doses administered as needed over the treatment period.
在治療期間使用所有需要的劑量後，所有病人所表現的激動症狀均有改善。
Before treatment with Igalmi, most patients exhibited mild to moderate agitation as assessed by the Agitation Calmness Evaluation Scale (ACES).
在接受Igalmi治療之前，大多數病人根據激動鎮靜評估量表（ACES）展現出輕度到中度的激動症狀。
ACES scores post-dose revealed a marked calming effect, with no patient experiencing unarousable somnolence.
劑量後的ACES評分顯示明顯的鎮靜效果，並且沒有任何病人出現無法喚醒的嗜睡。
In addition, no withdrawal or rebound phenomena were observed.
此外，未觀察到任何的戒斷或反彈現象。
The 180 mcg dose of Igalmi was generally well tolerated and showed favorable safety results in treating patients with frequent episodes of agitation.
使用180毫克劑量的Igalmi在治療頻繁激動症狀的病人中，普遍耐受性好，並且表現出良好的安全性。
There were no discontinuations due to adverse events. No serious adverse events were reported.
由於不良事件，沒有病人停止治療。未報告任何嚴重不良事件。
"We are pleased these study findings showed consistent responses to PRN treatment for episodes of agitation over the study duration with no evidence of worsening or withdrawal," said Rob Risinger, Chief Medical Officer of Neuroscience.
“我們很高興這些研究結果表明，在研究期間對PRN治療激動的反應始終保持一致，沒有惡化或戒斷的證據，”神經科學首席醫學官Rob Risinger說。
Price Action: BTAI shares are up 2.10% at $1.215 at last check Tuesday.
價格走勢：BTAI股價在週二上漲2.10%，報1.215美元。
Photo via Shutterstock
圖片來自shutterstock。