Published Research - Pharmaceutical

[Betty/WV]

Sleepdancer: (neat name for a RLSer) How high of a dose of Mirapex were you on. Just curious.

BETTY/WV

[sleepdancer]

I will have to find some old documentation, as it's been a few years and I'm afraid if I speak from memory I might not be accurate. I do remember that I was taking 4 pills, just don't remember the dosage of the pill. My memory is it was a whole number, but I'm just not certain. If I can locate that info I'll post it. (In the process of preparing to move, so things are packed away.)

[ViewsAskew]

New research- 5 year study of augmentation of Neupro/Rotigotine (not currently available in US)

[ViewsAskew]

New drug in Phase 1 trials - it's 8-15 years, IIRC from Phase 1 to marketing, so if this works, we won't see it for awhile. I wonder what it's based on...

Link

[ViewsAskew]

Phase IIb for IPX159 - in Clinical Trials now. It will be at several years, if this works, but it makes me happy that people are finding new therapies. This sounds as if it's not something we've seen before.

http://finance.yahoo.com/news/impax-pha ... 00622.html

AYWARD, Calif.--(BUSINESS WIRE)-- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL - News), announced that it has initiated a Phase IIb trial of its drug candidate IPX159 in patients with moderate to severe Restless Legs Syndrome (RLS).

“We are pleased to advance IPX159 to this Phase IIb study, which will help establish its clinical profile in moderate to severe RLS patients. We look forward to reporting the results from this study and providing an update on the program in mid-2013,” said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.

The Phase IIb study is a multicenter, randomized, double-blind, placebo-controlled, safety and efficacy study to evaluate IPX159 in the treatment of moderate to severe RLS. The trial is expected to randomize approximately 120 adult subjects who will receive either IPX159 or placebo and will be treated for up to 11 weeks. The trial will be conducted at multiple sites in North America. The primary endpoint is the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale.

About IPX159

IPX159 is an oral controlled-release formulation of a small molecule that has an established pharmacological and safety profile for non-RLS use outside the U.S. and may represent a novel mechanism of action in RLS. Impax has previously completed a proof of concept study with the molecule in RLS patients.

About Restless Legs Syndrome

Restless Legs Syndrome (RLS) is a condition characterized by an irresistible urge to move ones’ limbs, most commonly the legs, to stop uncomfortable sensations. RLS symptoms generally worsen in the evening, are made worse by rest or inactivity, and commonly cause insomnia and involuntary leg movements during sleep. There are approximately 25 million RLS sufferers in the US.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax is headquartered in Hayward, California, with a full range of capabilities located in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

To the extent any statements made in this news release contain information that is not historical, including the statements under the heading “2011 Financial Outlook,” these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the effect of current economic conditions on the Company’s industry, business, financial position and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer or a reduction in sales of any significant product, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the inexperience of the Company in conducting clinical trials and submitting new drug applications, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the pharmaceuticals and healthcare industries, the regulatory environment, the ability to protect the Company’s intellectual property, exposure to product liability claims and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and Impax undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

[cornelia]

I hope it will be a different med, but I wonder if this drug could be a controlled-release Pregabalin (Lyrica)?

Corrie

[ViewsAskew]

I hope it will be a different med, but I wonder if this drug could be a controlled-release Pregabalin (Lyrica)?

Corrie

It doesn't say anything about it being related to another drug - I thought they usually did that if it was. They also say it may represent a novel mechanism of action in RLS - I'd think that anything that already exists wouldn't be novel...but I certainly don't know that for sure!

[ViewsAskew]

Not really research....

But Neupro will be available in the US again by July 2012. It was just approved by the FDA.

http://www.marketwatch.com/story/repeat ... 2012-04-03

[Chipmunk]

It sounds like it is a new dopamine agonist, like Mirapex. I wonder if the patch delivery system will help reduce the risk of augmentation.

[rthom]

good thought

[ViewsAskew]

Yes, the patch delivery is supposed to reduce augmentation. it was here is the States in 2008 (guessing) and then pulled requiring reforumlation of the adhesive. I don't know many people who use it during that time.

[cornelia]

If I remember correctly augmentation on the patch is 10%.
Corrie

[Dancing Donna]

to update this thread, a great web site to go to is www.rlshelp.org which is Dr. Buchfuhrer's web site, a medical advisor to the board of the RLS Foundation. The treatment page is golden, updated all the time, and also the list of "Drugs and Foods to Avoid" is on that same page so all info is in one place. Lots of patient letters to read going back to 1998, so there is a lot there. Knowing what prescription meds and over the counter meds to avoid ae just as important as what to try and take in the trial and error portion of your RLS journey. Dr. Buchfuhrer has helped me so many times over the years I just cannot count. He always answers emails within 24 to 48 hrs.

[ViewsAskew]

This thread is about research as it's done, so it's been added to over several years. We have links to Dr Bs page in another location. See the New to RLS Section and the sticky posts there for that.

[ViewsAskew]

Interesting! Neurpro supposedly reduced PLMs and blood pressure that tends to rise from those PLMs.

http://www.thepharmaletter.com/file/122 ... tient.html

New study shows UCB's Neupro reduces NSBP in RLS patient

Article | 17 May 2013

Leading Belgian drugmaker UCB (Euronext Brussels: UCB) today (May 17) announced data from a double-blind, placebo-controlled study that found that Neupro (rotigotine transdermal system) reduced total nocturnal systolic blood pressure (NSBP) elevations associated with periodic limb movements during sleep (PLMS) and total PLMS in patients with idiopathic moderate-to-severe Restless Legs Syndrome (RLS)/Willis-Ekbom disease. The data were presented at the Annual Scientific Meeting of the American Society of Hypertension, May 15-18, 2013.

The data showed that rotigotine reduces PLMS and associated total nocturnal systolic blood pressure (NSBP) elevations in patients with RLS. Research has found that episodic nocturnal blood pressure excursions coincide with PLMS, possibly increasing the risk of hypertension and cardiovascular disease.

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Neupro is approved in the USA for the treatment of moderate-to-severe primary RLS. Neupro is also approved in the European Union for the symptomatic treatment of moderate-to-severe idiopathic RLS in adults.

"Our understanding of the extent to which RLS affects health is broadening. We are increasingly becoming aware of new organ systems that interact with this complex neurological disorder, going beyond symptoms of leg discomfort. The association of RLS with cardiovascular risk suggests that this disorder has unintended bed fellows," said David Rye, Professor of Neurology, Emory University School of Medicine, quoted by UCB, adding: "The data demonstrate the potential impact of Neupro upon nocturnal blood pressure elevations that coincide with periodic limb movements, a sign present in nearly all RLS patients. These findings beg for additional research into the pathophysiological underpinnings of this association and the potential new vistas it suggests into the control and treatment of both cardiovascular disease and RLS."

RLS is an often misdiagnosed and undertreated condition that affects an estimated 23 million Americans. PLMS occur in up to 90% of patients with RLS, and autonomic activation, associated with PLMS, has been linked to blood pressure increases in these RLS patients.

Study details

The study randomized 81 RLS patients (1:1) to receive an optimal dose of rotigotine (1mg/24hr, 2mg/24hr, or 3mg/24hr) or placebo. Continuous beat-by-beat blood pressure and heart rate assessments were performed at baseline and at the end of four-week maintenance. The primary outcome was a change from baseline to end of maintenance in the number of NSBP elevations associated with PLMS. Changes from baseline in total NSBP elevations and PLM index (PLMI) were also assessed.

Of the 66 RLS patients who completed the study, 37 received rotigotine and 29 received placebo. Mean (+SD) baseline PLMI was similar between rotigotine (72.9+55.6) and placebo (69.9+47.9). Patients with PLM-associated NSBP elevations (~300 elevations at baseline) saw greater reductions with rotigotine versus placebo. Total NSBP elevations (~785 elevations) decreased more in patients using rotigotine versus placebo. Rotigotine users also experienced greater decreases from baseline to end of maintenance in PLMI versus placebo. These results indicate that rotigotine reduced PLM-associated and total NSBP elevations in patients with RLS. Adverse events were consistent with dopaminergic stimulation and transdermal application. A total of 15 patients (rotigotine: 4/40; placebo: 11/41) discontinued prematurely.