Preclinical Development of SCP-123 for Neuropathic Pain
SCP-123治疗神经性疼痛的临床前开发
基本信息
- 批准号:7943138
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2003
- 资助国家:美国
- 起止时间:2003-09-15 至 2012-08-31
- 项目状态:已结题
- 来源:
- 关键词:AcetaminophenAcuteAddressAdverse effectsAffectAmericanAmitriptylineAnalgesicsAnimal ModelAnimalsAnticonvulsantsAntidepressive AgentsApplications GrantsCarboxylic AcidsChronicChung modelClinicalClinical ResearchClinical TrialsCodeineCollaborationsControlled Clinical TrialsCountryData AnalysesDevelopmentDoseDrug FormulationsDrug KineticsDrug PackagingEvaluationEventFundingGlutathioneGrantHealthHealth SciencesHepatotoxicityHistologyHumanInjuryIntravenousKidneyLeadLethal Dose 50LifeLigationLiverMeasuresMethodsModelingMorphineMusNerveNeuropathyNon-Steroidal Anti-Inflammatory AgentsOpiatesOpioidOralPainPamphletsParentsPatientsPharmaceutical PreparationsPharmacologic SubstancePhasePlacebo EffectPositioning AttributePropertyProtocols documentationPublishingRadiolabeledRattusReportingResearchResearch ContractsResearch DesignResearch PersonnelResearch Project GrantsResistanceRodent ModelRotarod Performance TestSafetySeriesSmall Business Innovation Research GrantSolidSolutionsSpinal nerve structureSyndromeTestingTherapeuticThermal HyperalgesiasTopical agentToxic effectTransaminasesTranslational ResearchTricyclic Antidepressive AgentsWaterWorkWritingallodyniaanalogbasechronic constriction injuryconstrictiondrug developmentdrug discoverygabapentingastrointestinalinterestmanmechanical allodyniamotor deficitpainful neuropathypre-clinicalpreclinical safetypreclinical studyradiotracerresearch studyresponsesafety studysciatic nervetrendwater solubility
项目摘要
DESCRIPTION (provided by applicant): Chronically, medically resistant pain is one of the most significant health problems in our country and affects more than 50 million Americans. Neuropathic pain syndromes are for the most part resistant to traditional analgesic treatments with NSAIDs, acetaminophen, or opiate medications (eg, morphine, codeine). Furthermore, most therapeutics currently used to treat neuropathic pain, including some antidepressants (eg, amitriptyline) and anticonvulsants (eg, gabapentin), were not specifically developed for that purpose, and show efficacy in only a fraction of the patients. We have been exploring a series of new and proprietary acetaminophen analogs, in which the lead compound (SCP-1) and it's active metabolite (SCP-123) show a favorable safety profile and are active in rodent models of neuropathic pain. In the first year under this Phase II SBIR translational research project, we will evaluate both an oral solid and an intravenous (iv) solution of SCP-123 in three models of neuropathic pain and compare them to gabapentin. We will also evaluate the safety and pharmacokinetic profile of these two formulations. When these evaluations are complete, we will analyze the data and choose one of the formulations as a clinical candidate. In the second and third year of this grant we will conduct the preclinical studies (on the chosen formulation) that are necessary for an Investigative New Drug (IND) application to the FDA. At the end of the third year of this grant project, we will write and assemble the IND package and submit it to the FDA. If the FDA accepts the IND application, we will shortly thereafter begin the Phase I human clinical of SCP-123 Chronically, medically resistant pain is one of the most significant health problems in our country and affects more than 50 million Americans. Patients with neuropathic pain are often treated with medications from different drug classes including tricyclic antidepressants, anticonvulsants, topical agents, and opioids, but the use of these pharmacological agents is limited both because of lack of efficacy and/or the occurrence of undesirable side-effects. St Charles Pharmaceuticals is proposing to develop a new class of compounds that have activity in neuropathic pain models and hold the promise of addressing the shortcomings of current treatments.
描述(由申请人提供):长期以来,医学抗性疼痛是我国最重要的健康问题之一,影响着5000多万美国人。神经性疼痛综合征大多数对传统的NSAID、对乙酰氨基酚或阿片类药物(如吗啡、可待因)的镇痛治疗有抵抗力。此外,目前用于治疗神经性疼痛的大多数治疗药物,包括一些抗抑郁药(如阿米替林)和抗惊厥药(如加巴喷丁),并不是专门为该目的开发的,并且仅在一小部分患者中显示出疗效。我们一直在探索一系列新的和专有的对乙酰氨基酚类似物,其中先导化合物(SCP-1)及其活性代谢物(SCP-123)显示出良好的安全性,并在啮齿动物神经性疼痛模型中具有活性。在第二阶段SBIR转化研究项目的第一年,我们将在三种神经性疼痛模型中评估SCP-123的口服固体和静脉注射(iv)溶液,并将其与加巴喷丁进行比较。我们还将评估这两种制剂的安全性和药代动力学特征。当这些评估完成后,我们将分析数据并选择其中一种制剂作为临床候选制剂。在第二年和第三年,我们将进行临床前研究(对选定的配方),这是向FDA申请研究性新药(IND)所必需的。在该资助项目的第三年年底,我们将编写并组装IND包,并将其提交给FDA。如果FDA接受IND申请,我们将在此后不久开始SCP-123的I期人体临床研究。慢性、医学上难以治愈的疼痛是我国最严重的健康问题之一,影响着5000多万美国人。患有神经性疼痛的患者通常用来自不同药物类别的药物治疗,包括三环类抗抑郁药、抗惊厥药、局部药物和阿片类药物,但是这些药理学药物的使用由于缺乏功效和/或发生不期望的副作用而受到限制。圣查尔斯制药公司正在提议开发一类新的化合物,这些化合物在神经性疼痛模型中具有活性,并有望解决目前治疗方法的缺点。
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kenneth W Narducy其他文献
Kenneth W Narducy的其他文献
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{{ truncateString('Kenneth W Narducy', 18)}}的其他基金
Preclinical Development of SCP-123 for Neuropathic Pain
SCP-123治疗神经性疼痛的临床前开发
- 批准号:
7561562 - 财政年份:2003
- 资助金额:
-- - 项目类别:
Preclinical Development of SCP-123 for Neuropathic Pain
SCP-123治疗神经性疼痛的临床前开发
- 批准号:
7503498 - 财政年份:2003
- 资助金额:
-- - 项目类别:
Preclinical Development of SCP-123 for Neuropathic Pain
SCP-123治疗神经性疼痛的临床前开发
- 批准号:
7327002 - 财政年份:2003
- 资助金额:
-- - 项目类别:
Preclinical Development of SCP-123 for Neuropathic Pain
SCP-123治疗神经性疼痛的临床前开发
- 批准号:
7560985 - 财政年份:2003
- 资助金额:
-- - 项目类别:
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