Drugs / IPX066
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed juvenile-onset Parkinson disease 1 milestone | |||||
| Filed | US (FDA) | — | juvenile-onset Parkinson disease | 2011-12-21 | “today announced the submission of Impax’s New Drug Application (NDA) for IPX066 to the U.S. Food and Drug Administration ( FDA )” amneal.com ↗ |
| Filed Parkinson disease 3 milestones | |||||
| Filed | EU (EMA) | — | Parkinson disease | 2014-11-06 | “today announced that it has submitted a Marketing Authorization Application for IPX066 to the European Medicines Agency (EMA).” amneal.com ↗ |
| Filed | US (FDA) | RYTARY | Parkinson disease | 2014-04-11 | “announced today the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration ( FDA ).” amneal.com ↗ |
| Rejected (CRL) | US (FDA) | RYTARY | Parkinson disease | 2013-01-21 | “the U.S. Food and Drug Administration ( FDA ) issued a complete response letter regarding the New Drug Application (NDA) for RYTARY™ (IPX066)” amneal.com ↗ “RYTARY as a result of a Complete Response Letter received in 2014” amneal.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01411137 | Aug 2011 → Mar 2013 | Parkinson disease | Impax Laboratories, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01130493 | May 2010 → Jan 2012 | Parkinson disease | Impax Laboratories, LLC | Completed | Met primary |
| Phase 3 | NCT01096186 | Mar 2010 → Oct 2011 | Parkinson disease | Impax Laboratories, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00880620 | Apr 2009 → Oct 2010 | Parkinson disease | Impax Laboratories, LLC | Completed | Met primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2017-11-09 | Impax Laboratories, LLC | Results Impax Reports Third Quarter 2017 Results amneal.com ↗
In the multiple dose Phase 2b study, patients achieved an average 2.2 hours reduction in "Off" time during the IPX203 treatment period compared to during the IR CD-LD treatment period and 2.0 hours improvement in "Good On" time based on patient diary data. |
| 2015-09-25 | Impax Laboratories, LLC | Regulatory Impax Receives Positive CHMP Opinion for NUMIENT™ (Levodopa and Carbidopa) Modified-Release Capsules for the Symptomatic Treatment of Adult Patients with Parkinson's disease amneal.com ↗
The positive opinion from the CHMP recommending the approval of NUMIENT is a significant step forward to providing a new treatment option to patients in Europe suffering from Parkinson's disease, |
| 2015-01-08 | Impax Laboratories, LLC | Regulatory Impax Pharmaceuticals Announce FDA Approval of RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules for the Treatment of Parkinson's disease amneal.com ↗
Today's approval of RYTARY is also a significant milestone for Impax because it is our first branded drug internally developed and approved for commercialization. |
| 2014-11-06 | Impax Laboratories, LLC | Regulatory Impax Submits Marketing Authorization Application to EMA for IPX066 (Carbidopa-Levodopa) Extended-Release Capsules amneal.com ↗
AMSTERDAM , Nov. 6, 2014 /PRNewswire/ -- Impax Laboratories ( Netherlands ) B.V., a wholly owned subsidiary of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it has submitted a Marketing Authorization Application for IPX066 to the European Medicines Agency (EMA). |
| 2014-09-17 | Impax Laboratories, LLC | Regulatory Impax Pharmaceuticals Announces Extension of RYTARY™ FDA Review Date to January 9, 2015 amneal.com ↗ |
| 2014-05-01 | Impax Laboratories, LLC | Regulatory Impax Laboratories Reports First Quarter 2014 Results amneal.com ↗
FDA Accepts RYTARY™ NDA Resubmission; Sets PDUFA Date of October 9, 2014 |
| 2014-04-11 | Impax Laboratories, LLC | Regulatory Impax Pharmaceuticals Resubmits New Drug Application for RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) amneal.com ↗
Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration ( FDA ). |
| 2013-01-21 | Impax Laboratories, LLC | Regulatory FDA Issues Complete Response Letter for RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) New Drug Application amneal.com ↗ |
| 2012-10-12 | Impax Laboratories, LLC | Regulatory Impax Pharmaceuticals Announces Extension of RytaryTM FDA Review Date to January 21, 2013 amneal.com ↗
the U.S. Food and Drug Administration ( FDA ) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Rytary TM (IPX066) New Drug Application (NDA) from October 21, 2012 , to January 21, 2013 . |
| 2012-02-23 | Impax Laboratories, LLC | Regulatory FDA Accepts Impax Pharmaceuticals NDA Filing for IPX066 for the Treatment of Idiopathic Parkinson’s Disease amneal.com ↗ |
| 2011-12-21 | Impax Laboratories, LLC | Regulatory Impax Pharmaceuticals Submits New Drug Application for IPX066 in Parkinson’s Disease amneal.com ↗ |
| 2011-08-15 | Impax Laboratories, LLC | Results Impax and GSK Announce Positive Topline Results of ASCEND-PD Phase III Study of IPX066 in Advanced Parkinson's Disease amneal.com ↗
Impax Pharmaceuticals,the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) and GlaxoSmithKline (GSK) today announced top-line results of the ASCEND-PD Phase III clinical study of IPX066 versus carbidopa-levodopa plus entacapone (CLE), in patients with advanced Parkinson's disease (PD). |
| 2011-03-14 | Impax Laboratories, LLC | Results IPX066 Demonstrates Efficacy and Safety in ADVANCE-PD Phase III Study in Treatment of Advanced Parkinson's Disease amneal.com ↗
IPX066 met the primary end point, significantly reducing percentage of "off time" over IR CD-LD |
| 2010-11-18 | Impax Laboratories, LLC | Results Impax Pharmaceuticals Announces IPX066 Demonstrates Efficacy and Safety in APEX-PD Phase III Study in Treatment of Early Parkinson's Disease amneal.com ↗ |
| 2009-09-21 | Impax Laboratories, LLC | Results Impax Pharmaceuticals Reports Positive Results of Phase II Trial of IPX066, a Novel Formulation of Carbidopa-Levodopa for Parkinson’s Disease amneal.com ↗
Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today reported the positive results from a recently completed Phase II trial of its late-stage Parkinson’s Disease drug candidate IPX066 |
| 2009-04-20 | Impax Laboratories, LLC | Results Impax Pharmaceuticals Reports Positive Achievements on its Two Leading Brand Product Candidates IPX066 and IPX056 amneal.com ↗
The interim results of this Phase II study have demonstrated consistent signals of superior clinical benefit in both extended pharmacokinetic profile and control of PD motor symptoms compared to conventional carbidopa levodopa. |
| 2008-08-07 | Impax Laboratories, LLC | Regulatory IMPAX Reports Positive Results in Phase III Trial with IPX056 amneal.com ↗
The Company filed an Investigational New Drug application for IPX066, a controlled-release formulation of Carbidopa/Levodopa in July 2008, and expects to initiate studies in Parkinson ’ s disease patients by the end of this year and is targeting an NDA submission in mid-2011. |
All press releases naming this drug 32 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IPX066 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01096186 ↗ |
| Known as | Rytary | “BACKGROUND: IPX066 (Rytary®; carbidopa and levodopa [CD-LD] extended-release capsules) was designed to achieve therapeutic LD plasma concentrations within 1h of dosing and...” PMID 28131167 ↗ Nov 2016 |
| Route | Oral | “BACKGROUND: IPX066 is an extended-release (ER) oral formulation of carbidopa-levodopa (CD-LD).” PMID 30425824 ↗ Oct 2018 |