নুপ্লাজিড, একটি নির্বাচনী সেরোটোনিন ইনভার্স অ্যাগোনিস্ট, 2022 সালে নতুন ইঙ্গিতগুলির জন্য আবেদন করবে!

Acadia Pharmaceuticals is committed to developing innovative therapies to treat central nervous system (CNS) diseases. Recently, the company announced that it plans to resubmit Nuplazid's (pimavanserin) Supplemental New Drug Application (sNDA) for the treatment of hallucinations and delusions associated with Alzheimer's Psychiatric (ADP) dementia. sNDA plans to resubmit to the US FDA in the first quarter of 2022.

The resubmission of the sNDA is intended to prove that Nuplazid has clinically significant benefits for ADP patients without deteriorating the cognitive or motor function of the elderly. The resubmitted data will include study data from two placebo-controlled studies: the key Phase 3 HARMONY study and the HARMONY-019 study. At the same time, other analyses of HARMONY and HARMONY-019 will be provided to verify the main conclusions of each study and resolve the issues raised in the FDA's complete response letter (CRL).

Acadia CEO Steve Davis said: "After our recent meeting with the FDA, we plan to resubmit Nuplazid's sNDA, narrowing the proposed indication from dementia-related psychosis to Alzheimer's disease psychosis. The resubmitted sNDA will include A new analysis of existing clinical research data supports Nuplazid's treatment of hallucinations and delusions associated with Alzheimer's psychosis. If approved, Nuplazid will become the first drug used to treat Alzheimer's psychosis."

পিমাভান্সেরিনের রাসায়নিক গঠন (ছবির উত্স: chemicalbook.com)

নুপ্লাজিডের সক্রিয় ফার্মাসিউটিক্যাল উপাদান হল পিমাভান্সেরিন, যা একটি নির্বাচনী সেরোটোনিন ইনভার্স অ্যাগোনিস্ট এবং প্রতিপক্ষ যা 5-HT2A রিসেপ্টরকে পছন্দ করে। এই রিসেপ্টরগুলি নিউরোসাইকিয়াট্রিক রোগে গুরুত্বপূর্ণ ভূমিকা পালন করে বলে মনে করা হয়। ভিট্রোতে, ডোপামিন (D2 সহ), হিস্টামিন, মুসকারিনিক বা অ্যাড্রেনার্জিক রিসেপ্টরগুলির জন্য পিমাভান্সেরিনের কোনও সুস্পষ্ট বাঁধাইয়ের সম্পর্ক নেই।

Nuplazid was approved by the US FDA in May 2016 for the treatment of hallucinations and delusions associated with Parkinson's disease (PD) psychosis. Previously, the FDA had granted Nuplazid Breakthrough Drug designation in 2014. Nuplazid is the first drug approved by the FDA to treat hallucinations and delusions associated with Parkinson's disease. The approval of Nuplazid on the market marks a major milestone in the clinical treatment of Parkinson's disease and psychosis.

Nuplazid's unique pharmacology has created a new class of drugs—selective serotonin inverse agonists (SSIA), which not only preferentially target 5-HT2A receptors, but also avoid the common features of most schizophrenia drugs Dopamine receptors and other receptor activation side effects. Conventional Parkinson's disease therapy contains drugs that stimulate dopamine to treat patients' motor symptoms such as tremor, muscle stiffness, and difficulty walking. Nuplazid has a novel selective mechanism of action to treat hallucinations and delusions with a new mode of action. The drug does not have dopamine receptor activity and does not interfere with patients' dopaminergic therapy, so it will not affect the motor function of patients with Parkinson's.

In April 2021, Nuplazid's New Indication Application (sNDA) for the treatment of hallucinations and delusions related to dementia-related psychosis (DRP) was rejected by the US FDA. The FDA issued a complete response letter (CRL) to the company stating that it has completed the sNDA review and determined that the sNDA cannot be approved in its current form. The CRL pointed out that certain subtypes of dementia lack statistical significance. At the same time, the number of patients with certain less common subtypes of dementia is insufficient, and there is a lack of effective evidence to support approval.

ডিআরপি-এর সাথে যুক্ত হ্যালুসিনেশন এবং বিভ্রান্তির চিকিৎসার জন্য নুপ্লাজিডকে অনুমোদন দেওয়া হয়নি। বর্তমানে, Acadia অন্যান্য নিউরোসাইকিয়াট্রিক রোগে পিমাভান্সেরিন তৈরি করছে।