Tanlangan serotonin teskari agonisti Nuplazid 2022 yilda yangi ko'rsatkichlar uchun murojaat qiladi!

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."

Pimavanserinning kimyoviy tuzilishi (rasm manbasi: kimyoviybook.com)

Nuplazidning faol farmatsevtik moddasi pimavanserin bo'lib, u selektiv serotonin teskari agonisti va antagonisti bo'lib, 5-HT2A retseptorlarini afzal ko'radi. Ushbu retseptorlarning neyropsikiyatrik kasalliklarda muhim rol o'ynashi taxmin qilinadi. In vitroda pimavanserinning dofamin (shu jumladan D2), gistamin, muskarinik yoki adrenergik retseptorlari bilan aniq bog‘lanish xususiyati yo‘q.

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.

Nuplazid DRP bilan bog'liq gallyutsinatsiyalar va aldanishlarni davolash uchun tasdiqlanmagan. Hozirgi vaqtda Acadia boshqa nevropsikiyatrik kasalliklarda pimavanserinni rivojlantirmoqda.