A Double-Blind, Randomised, Placebo-Controlled, Two-Phase Study (a Single Ascending Dose Phase Followed by a Proof of Concept Phase) to Assess the Safety, Efficacy and Pharmacokinetics of FX005 (50:50 PLGA) Microspheres for the Treatment of Pain in Osteoarthritis of the Knee.

开始日期2011-01-11

申办/合作机构

Flexion Therapeutics, Inc.

NCT01291914 / Completed临床1/2期

A Double-Blind, Randomized,Placebo-Controlled, Two-Phase Study (a Single Ascending Dose Phase Followed by a Proof of Concept Phase) to Assess the Safety, Efficacy and Pharmacokinetics of FX005 for the Treatment of Pain in Osteoarthritis of the Knee

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.

开始日期2010-12-01

申办/合作机构

Pacira Biosciences, Inc.

100 项与 FX-005 相关的临床结果

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100 项与 FX-005 相关的转化医学

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100 项与 FX-005 相关的专利（医药）

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项与 FX-005 相关的文献（医药）

2019-03-04·Expert Opinion on Pharmacotherapy3区 · 医学

An indirect treatment comparison of the efficacy of patisiran and tafamidis for the treatment of hereditary transthyretin-mediated amyloidosis with polyneuropathy

3区 · 医学

Review

作者: Fahrbach, Kyle ; Lin, Hollis ; Chitnis, Madhura ; Polydefkis, Michael ; Agarwal, Sonalee ; Planté-Bordeneuve, Violaine ; Gollob, Jared ; Betts, Marissa

BACKGROUNDHereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) is a progressive, life-threatening disease. Until recently, tafamidis was the only approved pharmacotherapy. Patisiran significantly improved polyneuropathy and quality of life (QoL) in the phase III APOLLO trial. In the absence of direct comparisons, this analysis aimed to evaluate the comparative efficacy of tafamidis and patisiran in hATTR amyloidosis with polyneuropathy.RESEARCH DESIGN AND METHODSRandomized controlled trial evidence for tafamidis was identified by systematic literature review. Indirect treatment comparisons were performed using the standard pairwise Bucher method for endpoints used in both APOLLO and the tafamidis Fx-005 trial: change from baseline in Neuropathy Impairment Score-lower limbs (NIS-LL), Norfolk QoL-Diabetic Neuropathy questionnaire (QoL-DN), NIS-LL response, and mBMI vs. placebo. Inter-trial population differences were assessed by sensitivity analysis.RESULTSThe base-case analysis (FAP Stage 1 APOLLO patients vs. intent-to-treat Fx-005 population) suggested patisiran had a greater treatment effect vs. tafamidis for all endpoints, with significant improvements in mean change in NIS-LL (-5.49) and QoL-DN (-13.10) from baseline to Month 18. Similar trends were observed in all sensitivity analyses.CONCLUSIONSIn the absence of direct comparisons, this analysis suggests patisiran has a greater treatment effect than tafamidis in patients with hATTR amyloidosis with polyneuropathy.

2015-12-01·Neurology and Therapy3区 · 医学

A Review of Tafamidis for the Treatment of Transthyretin-Related Amyloidosis

3区 · 医学

ArticleOA

作者: Benson, Merril D ; Waddington Cruz, Márcia

Transthyretin (TTR)-related amyloidosis (ATTR) is a devastating disease which affects a combination of organs including the heart and the peripheral nerves, and which has a fatal outcome if not treated within a average of 10 years. Tafamidis, or 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylic acid, selectively binds to TTR with negative cooperativity and kinetically stabilizes wild-type native TTR and mutant TTR; tafamidis therefore has the potential to halt the amyloidogenic cascade initiated by TTR tetramer dissociation, monomer misfolding, and aggregation. The first tafamidis trial, Fx-005, evaluated the effect of 18 months of tafamidis treatment (20 mg once daily) on disease progression, as well as assessing its safety in TTR-FAP Val30Met patients. The secondary objective of this trial was to study the pharmacodynamic stabilization of mutated TTR. Tafamidis proved effective in reducing the progress of neuropathy, and in maintaining the nutritional status and quality of life of stage 1 (able to walk without support) Val3OMet TTR-FAP patients. Furthermore, TTR stabilization was achieved in more than 90% of patients. An extension study, Fx-006, was conducted to determine the long-term safety and tolerability of tafamidis and to assess the efficacy of the drug on slowing disease progression. No significant safety or tolerability issues were noticed. Taken together, the results from both trials indicated that the beneficial effects of tafamidis were sustained over a 30-month period and that starting treatment early is desirable. Results are expected from an extended open-label study but data that have already been presented show that long-term use of tafamidis in Val30Met patients is associated with reduced progression in polyneuropathy. Tafamidis was initially approved for commercial use in Europe in 2011 and has since been approved for use in Japan, Mexico, and Argentina where it is used as a first-line treatment option for patients with early-stage TTR-FAP. Patients should be carefully followed at referral centers to ascertain the individual response to treatment. In cases of discontinuation, liver transplantation and enrollment in clinical trials of novel drugs aimed mostly toward suppression of TTR production are options.

100 项与 FX-005 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
膝关节炎	申请上市	奥地利	Flexion Therapeutics, Inc.	2010-12-01
膝关节炎	申请上市	英国	Flexion Therapeutics, Inc.	2010-12-01
膝关节炎	申请上市	加拿大	Flexion Therapeutics, Inc.	2010-12-01
膝关节炎	申请上市	西班牙	Flexion Therapeutics, Inc.	2010-12-01
疼痛	临床2期	-	Flexion Therapeutics, Inc.	-