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Impax announces positive top-line results of Phase III IPX066 study for Parkinson's disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced positive top-line results of the APEX-PD Phase III clinical study with IPX066 in Parkinson's disease (PD). IPX066 is a novel extended release carbidopa-levodopa product.

19 Nov 2010

Michael J. Fox Foundation for Parkinson's Research announces awards totaling $10.1M

The Michael J. Fox Foundation for Parkinson's Research announced awards totaling approximately $10.1 million for five new clinical studies and 14 pre-clinical therapeutic development projects. The funding includes $2.5 million to drive four new clinical trials under the Clinical Intervention Awards, one of the Foundation's Edmond J. Safra Core Programs for PD Research.

6 Oct 2010

NeuroDerm receives $1M grant for development of ND0611 dermal patch for Parkinson's disease

NeuroDerm, Ltd. was informed today that it was awarded a grant of $1M by The Michael J. Fox Foundation for Parkinson's Research. These funds will support the next clinical study with ND0611, a new dermal patch for the treatment of Parkinson's disease, as part of the Foundation's prestigious Clinical Intervention Awards 2010 program. This study will evaluate the safety, tolerability, levodopa pharmacokinetics, and possible clinical benefits of ND0611 in advanced Parkinson's disease patients.

6 Oct 2010

USFDA grants Sun Pharma tentative approval for generic Stalevo ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Orion's Stalevo® tablets.

1 Oct 2010

XenoPort to present XP21279 clinical trial data at World Parkinson Congress meeting

XenoPort, Inc. announced today that new data from its first clinical trial of XP21279, a Transported Prodrug of L-Dopa, in Parkinson's disease patients will be presented at the upcoming World Parkinson Congress meeting in Glasgow, Scotland.

29 Sep 2010

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced that it has completed enrollment of its ADVANCE-PD trial. ADVANCE-PD is a multinational Phase III trial of its late-stage product IPX066 in advanced Parkinson's disease (PD) patients with motor fluctuations. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management.

26 Aug 2010

Chelsea reports positive outcome from DMC review of droxidopa Phase II trial in fibromyalgia

Chelsea Therapeutics International, Ltd. announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.

2 Jul 2010

Aton Pharma acquires the U.S. marketing rights to LODOSYN tablets from BMS

Aton Pharma, Inc., a diversified specialty pharmaceutical company, today announced that it has acquired the U.S. marketing rights to LODOSYN (carbidopa) tablets from Bristol-Myers Squibb Company.

26 Apr 2010

Enrollment completed in Impax Pharmaceuticals' APEX-PD trial of IPX066

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced that it has completed enrollment of its APEX-PD trial. APEX-PD is a multinational Phase III trial of its late-stage drug candidate IPX066 in subjects with early Parkinson's disease.

16 Apr 2010

European markets for Parkinson's disease therapeutics to reach $2.28 billion in 2015

The Parkinson's disease therapeutics market in 2008 amounted to over $1 billion in the European Union (EU), which includes total sales of carbidopa/levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors and anticholinergics used for disease symptom relief.

9 Dec 2009

Impax Pharmaceuticals begins Phase III trial of IPX066 drug in PD patients

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ:IPXL), today announced that it has initiated a multinational Phase III trial of its late-stage drug candidate IPX066 in advanced Parkinson’s disease (PD) patients.

27 Oct 2009

FDA approves Mylan Pharmaceuticals' Carbidopa and Levodopa tablets

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg.

30 Sep 2009

Phase II trial of Impax Pharmaceuticals' Parkinson’s disease drug candidate successful

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

21 Sep 2009

Depomed reports promising results in phase I trial for DM-1992 in Parkinson’s

Depomed, Inc. (NASDAQ:DEPO) today announced that in its Phase 1 pharmacokinetic study in Parkinson’s patients, DM-1992, Depomed’s investigative novel gastric retentive extended-release formulation of levodopa/carbidopa, extended coverage above levodopa’s efficacious threshold and extended the time to peak levodopa concentration relative to currently available sustained release levodopa/carbidopa formulations.

11 Aug 2009

Dopamine agonists trigger destructive behaviors

A new study conducted at Mayo Clinic reports that one in six patients receiving therapeutic doses of certain drugs for Parkinson's disease develops new-onset, potentially destructive behaviors, notably compulsive gambling or hypersexuality.

9 Apr 2009

Submission of NDA for Istradefylline(KW-6002), an investigational anti-Parkinson's disease drug

Kyowa Hakko Kogyo Co. has announced that Kyowa Pharmaceutical, Inc., its wholly owned U.S subsidiary, submitted on April 25, 2007 a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Istradefylline(KW-6002), its investigational drug for Parkinson's disease.

30 Apr 2007

Withdrawal of Pergolide products

The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson's disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients' heart valves.

29 Mar 2007

Levodopa and pramipexole appear to be reasonable options as initial therapy for Parkinson disease

An article in the July issue of the Archives of Neurology reports that the drugs levodopa and pramipexole both appear to be reasonable options as initial therapy for Parkinson disease, but they are associated with different efficacy and adverse effects.

20 Jul 2004

IMPAX receives final FDA approval for generic version of Sinemet CR

IMPAX Laboratories, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for Carbidopa/Levodopa Extended Release Tablets, its generic version of Sinemet(R) CR tablets.

17 May 2004