PharmaTher Holdings Ltd. (OTCQB:PHRRF)'s recent meeting with the FDA on the feasibility of a Phase 3 program for proprietary ketamine KETARX to treat levodopa-induced dyskinesia in Parkinson's disease (LID-PD) was successful, considering the federal agency supported the company's overall approach.
Currently, there is no cure for this progressive neurodegenerative disorder, although some drug combinations are used to treat its symptoms, including levodopa and dopamine agonists which restore the brain's dopamine deficits but carry on motor-side effects that limit dose increases after a certain point.
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PharmaTher would then submit an IND application under the 505(b)(2) regulatory pathway following positive results from a single confirmatory trial. Further, the FDA advised the company to submit a Fast Track designation application.
Prior safety and efficacy results from its Phase 1/2 clinical trial on KETARX for the treatment of LID-PD will be used to advance studies into the proposed Phase 3 clinical stage.
Those results showed ketamine was safe, well-tolerated and provided a reduction in dyskinesias in all study participants, who had moderate to advanced Parkinson's prior to the study's commencement.
PharmaTher was previously granted a notice of allowance by the USPTO for its patent on compositions and methods for treating motor disorders covering its proprietary ketamine for the treatment of Parkinson's and other motor disorders and expects to get the patent issued in the coming months.
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PharmaTher Holdings Ltd.(OTCQB：PHRRF)最近與FDA就一項第三階段計劃專有的氯胺酮凱塔克斯考慮到聯盟機構支持該公司的整體方法，治療帕金森病左旋多巴誘導的運動障礙(LID-PD)是成功的。
目前，這種進行性神經退行性疾病還沒有治癒方法，儘管一些藥物組合被用來治療它的癥狀，包括左旋多巴和多巴胺激動劑，它們可以恢復大腦中的多巴胺缺乏，但會產生運動副作用，限制劑量在某個時間點後增加。
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然後，PharmaTher將根據505(B)(2)單一驗證性試驗陽性結果後的調控途徑。此外，FDA建議該公司提交快速通道指定申請。
KETARX治療LID-PD的1/2期臨床試驗的先前安全性和有效性結果將用於推進擬議的3期臨床階段的研究。
這些結果表明，氯胺酮是安全的，耐受性良好，並在所有研究參與者中提供了減少運動障礙的作用，這些參與者在研究開始前患有中重度帕金森氏症。
PharmaTher之前獲得了美國專利商標局的補貼通知，其治療運動障礙的組合物和方法的專利涵蓋了其治療帕金森氏症和其他運動障礙的專有氯胺酮，預計將在未來幾個月獲得專利頒發。
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圖片：Benzinga在Shutterstock上由woraatep suppaas編輯，Doc James在維基媒體上編輯。
