NuPathe - zurück am richtigen Pfad gen Norden!

NuPathe Reports Positive Top-Line Results From 12-Month, Repeat Use Safety Trial for Its Migraine Patch

Press Release Source: NuPathe Inc. On Monday October 3, 2011, 8:30 am EDT

CONSHOHOCKEN, PA--(Marketwire -10/03/11)- NuPathe Inc. (NASDAQ: PATH - News) today announced positive top-line results from NP101-009, its second 12-month, repeat use safety trial for its migraine patch (NP101 or Zelrix).

NP101-009 was designed to assess the long-term safety of the migraine patch. A total of 479 patients were enrolled and applied at least one patch. Consistent with the findings from previous studies, the incidence of adverse events known as triptan sensations, which can include chest tightness, flushing and feelings of pressure and numbness, was very low, with only four patients (0.8 percent) reporting a triptan sensation over the course of the 12-month trial.

"We now have treated more than 800 patients who applied greater than 10,000 patches in our Phase III clinical program," commented Mark Pierce, MD, Ph.D., chief scientific officer of NuPathe. "Our clinical data have consistently shown a very low rate -- 1.4 percent in fact -- of triptan sensations across patients who have used our patch to treat their migraine."

The most common adverse events in the NP101-009 study occurred at the patch application site and included: application site pain (18.6 percent of patients), application site itching (14.0 percent) and application site reaction (6.1 percent). During the 12-month trial, 13.4 percent of patients withdrew from the study due to adverse events, primarily related to the patch application site.

"Based on the extensive clinical data from our entire Phase III clinical program, we believe that our patch will provide a valuable new treatment option that is particularly well-suited for the millions of migraine patients who suffer from debilitating migraine-related nausea along with their headache pain," said Jane Hollingsworth, chief executive officer of NuPathe. "We plan to present detailed results from the NP101-009 trial at an upcoming scientific meeting."

On August 30, 2011, NuPathe announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its migraine patch. The Company believes that the complete data set for NP101-009 will be supportive of the resubmission of its NDA to the FDA.

About the Migraine Patch (NP101 or Zelrix)
NP101 is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine. The patch is designed to provide migraine patients fast onset and sustained relief of the cardinal migraine symptoms including headache pain, migraine-related nausea (MRN), and sensitivity to light and sound. The non-oral route of the migraine patch may provide an attractive treatment option for millions of migraine patients who delay or avoid treatment with oral medications because of MRN. The migraine patch provides a transdermal dose of sumatriptan, the most widely prescribed migraine medication, with low incidence of triptan sensations that can include chest tightness, flushing and feelings of pressure and numbness. In addition, studies have shown the gastrointestinal (GI) tract slows during a migraine attack. The migraine patch's delivery bypasses the GI tract, making it an appealing treatment option for many of these patients. The patch is powered by SmartRelief™, NuPathe's proprietary transdermal delivery technology. SmartRelief consists of a controlled delivery technology that rapidly transports medication through the skin using a process called iontophoresis.  

 

 

 

 

 

 

 

 

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NuPathe to Present at the Lazard Capital Markets 8th Annual Healthcare Conference
Nupathe Inc. (MM) (NASDAQ:PATH)
Today : Tuesday 8 November 2011


NuPathe Inc. (NASDAQ: PATH), an emerging biopharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, today announced that Jane Hollingsworth, chief executive officer, will present a company overview at the Lazard Capital Markets 8th Annual Healthcare Conference on Tuesday, November 15, 2011 at 2:30 p.m. EST. The conference is being held at the Pierre Hotel in New York, NY.
A live audio webcast of the presentation will be available via the "Investor Relations" page of the NuPathe website, www.nupathe.com. Please log on through NuPathe's website approximately 10 minutes prior to the scheduled start time. A replay of the webcast will also be archived on the Company's website for 90 days following the presentation.

About NuPathe

NuPathe Inc. (www.nupathe.com) is an emerging biopharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system including neurological and psychiatric disorders. NuPathe's lead product candidate, NP101, is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine. In addition to NP101, NuPathe has two additional proprietary product candidates in preclinical development: NP201 for the continuous symptomatic treatment of Parkinson's disease, which the company plans to partner, and NP202 for the long-term treatment of schizophrenia and bipolar disorder.

Contact Information:



John Woolford

Westwicke Partners, LLC

(443) 213-0506

john.woolford@westwicke.com



Keith A. Goldan

Vice President & Chief Financial Officer

NuPathe Inc.

(484) 567-0130  

Alexza Presents Staccato® Loxapine Responder Analyses in Agitated Adult Patients with
mo., 7.11. release von vierteljährlichem 10-Q, gestern bereits der 2. tag der langersehnten 24. health conference, alexza hat nach börsenschluß einen neuen 8-K veröffentlicht. interessant nun den weiteren kursverlauf zu beobachten...und die folgerichtigen schlüsse in den biotech-stats ablegen

Schizophrenia or Bipolar Disease at th...
Alexza (NASDAQ:ALXA)
Today : Wednesday 9 November 2011

Alexza Pharmaceuticals, Inc. (Nasdaq:  ALXA) today announced that it is presenting at the 24th Annual U.S. Psychiatric and Mental Health Congress, being held November 7 - 10, 2011.  The abstract and poster presentation, entitled "Treating Agitation with Inhaled Loxapine (AZ-004): Responder Analyses in Patients with Schizophrenia or Bipolar Disorder", is being presented today by Dr. James V. Cassella, Alexza's Senior Vice President of Research and Development.  Alexza has previously reported and presented the primary findings of its two Phase 3 clinical trials with Staccato loxapine.  In this presentation, Alexza is presenting additional analyses of these data, using two different responder methodologies.

Methodologies

The efficacy of Staccato loxapine in treating agitation was measured using the PANSS-Excited Component (PEC) and Clinical Global Impression - Improvement (CGI-I) scales in two Phase 3 randomized, double-blind, placebo-controlled trials in agitated patients with schizophrenia (n=344) or bipolar I disorder (n=314).  At the beginning of the treatment period, patients received a single inhalation of either 0mg (placebo), 5mg or 10mg of Staccato loxapine.  The primary endpoint was successfully achieved in both studies and has been previously reported and published.  As a further efficacy assessment, two responder analyses, PEC40 and CGI-Improvement, were conducted with responders defined as: (1) patients with a >40% decrease from baseline in the total PEC score (starting at 10 minutes post-dose); and (2) patients rated as "much improved" or "very much improved" on the CGI-I scale (assessed at 2 hours post-dose).  Responder analyses are important as they are a method to determine the magnitude of clinical relevance of patient response to a treatment.

PEC40 Responders Analysis

In agitated patients with schizophrenia or bipolar disorder, the number of PEC40 responders was statistically significantly greater at all time points for patients treated with either dose of Staccato loxapine, compared to patients who received Staccato placebo.  Importantly, significant differences from placebo were noted at the first assessment time of 10 minutes post-dose for both dose groups and in both patient groups.  The results for the PEC40 Responders analysis are summarized below.

Staccato Loxapine PEC40 Responder Analysis
Schizophrenia Patients
(% with >40% decrease from baseline PEC score)
5mg
10mg
Time Point
Placebo
Staccato Loxapine
Staccato Loxapine
10 minutes
6.1%
17.2%
18.8%
20 minutes
15.7%
29.3%
42.9%
30 minutes
27.8%
46.6%
57.1%
45 minutes
32.2%
50.0%
70.5%
60 minutes
38.3%
57.8%
71.4%
90 minutes
38.3%
61.2%
74.1%
120 minutes
38.3%
62.9%
69.6%
Staccato Loxapine PEC40 Responder Analysis
Bipolar Disorder Patients
(% with >40% decrease from baseline PEC score)
5mg
10mg
Time Point
Placebo
Staccato Loxapine
Staccato Loxapine
10 minutes
7.6%
18.3%
21.9%
20 minutes
15.2%
36.5%
49.5%
30 minutes
23.8%
59.6%
61.9%
45 minutes
29.5%
64.4%
70.5%
60 minutes
28.6%
69.2%
72.4%
90 minutes
27.6%
62.5%
72.4%
120 minutes
27.6%
62.5%
73.3%
CGI-I Responders Analysis

In patients with schizophrenia, 57.4% of the 5mg patients and 67.0% of the 10mg patients treated with Staccato loxapine were CGI-I responders, compared with 35.7% of placebo patients.  In patients with bipolar disorder, 66.3% of the 5mg patients and 74.3% of the 10mg patients treated with Staccato loxapine were CGI-I responders, compared with 27.6% of placebo patients.  In both patient populations, the CGI-I responders were statistically significantly greater for patients treated with either dose of Staccato loxapine, compared to patients who received Staccato placebo.  The results for the CGI-I Responders analysis are summarized below.

Staccato Loxapine CGI-I Responder Analysis
2-Hour CGI-Improvement
(% of Patients Rated as "Much Improved" or "Very Much Improved")
Schizophrenia
Bipolar Disorder
Staccato Loxapine Dose Group
Patients
Patients
10mg
67%
74%
5mg
57%
66%
Placebo
36%
28%
About Alexza Pharmaceuticals, Inc.

Alexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions.  Alexza's technology, the Staccato® system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.  The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience. (Click here to see an animation of how the Staccato system works.)

ADASUVE™ (Staccato loxapine) is Alexza's lead program, which is being developed for the acute treatment of agitation in adults with schizophrenia or bipolar disorder.  Alexza completed and announced positive results from both of its Phase 3 clinical trials and initially submitted the ADASUVE NDA in December 2009.  In October 2010, the Company received a Complete Response Letter from the FDA regarding the application.  The Company completed an end-of-review meeting with the FDA in December 2010 and a Risk Evaluation and Mitigation Strategy (REMS) guidance meeting with the FDA in April 2011.  The ADASUVE NDA was resubmitted on August 4, 2011 and has a Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.  The ADASUVE NDA will be presented to an advisory committee on December 12, 2011.

In October 2011, the Company established a commercial partnership for ADASUVE with Grupo Ferrer International, S.A.  Grupo Ferrer is a leading pharmaceutical company in Europe with extensive operations in the Americas, and is Alexza's partner in the commercialization of ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries.  Alexza filed its ADASUVE Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in October 2011.  

For more information about Alexza, the Staccato system technology or the Company's development programs, please visit www.alexza.com.  

sell on good news? oder mal eine richtige kurssteigerung...time will tell!

NuPathe to Report Third Quarter 2011 Results and Hold Conference Call on Monday, November 14, 2011
Nupathe Inc. (MM) (NASDAQ:PATH)
Today : Thursday 10 November 2011

NuPathe Inc. (NASDAQ: PATH), an emerging biopharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, will report third quarter 2011 results on Monday, November 14, 2011, after the close of the U.S. financial markets. NuPathe will also host a conference call at 4:30 p.m. EST on the same day to discuss its third quarter 2011 financial results and recent operational highlights. NuPathe will also discuss its November 9, 2011, meeting with the U.S. Food and Drug Administration (FDA) regarding the complete response letter for its migraine patch. A question-and-answer session will follow NuPathe's remarks.
To participate on the live call, please dial 877-675-4749 (domestic) or +1-719-325-4765 (international), and provide the participant passcode 2444740 five to ten minutes before the start of the call. A replay of the call will be available for 90 days within a few hours after the call ends. Investors may listen to the replay of the call by dialing 888-203-1112 (domestic) or +1-719-457-0820 (international), with the passcode 2444740.

A live audio webcast of the call will be also available via the "Investor Relations" page of the NuPathe website, www.nupathe.com. Please log on through NuPathe's website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on NuPathe's website for 90 days following the call.  

was an topnews kommen ...chart turns bullish!
http://ih.advfn.com/p.php?pid=nmona&article=50818449
http://finance.yahoo.com/q/sec?s=PATH+SEC+Filings  

 

 

 

 

 

 

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http://investorshub.advfn.com/boards/read_msg.aspx?message_id=73455675  

FDA Accepts NuPathe's Migraine Patch NDA Resubmission for Filing
Print
Alert
Nupathe Inc. (MM) (NASDAQ:PATH)
Intraday Stock Chart
Today : Tuesday 31 July 2012


NuPathe Inc. (NASDAQ: PATH), a biopharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, today announced that the company's New Drug Application (NDA) resubmission for its migraine patch (NP101) has been accepted for filing by the U.S. Food and Drug Administration (FDA). NuPathe has received a Prescription Drug User Fee Act (PDUFA) date, the target date for the FDA to complete its review of the NDA, of January 17, 2013.
"As important as FDA acceptance of our NDA resubmission is for NuPathe, we believe it's even more significant for the millions of migraine patients who suffer from headache pain and debilitating migraine-related nausea," said Armando Anido, chief executive officer of NuPathe. "We look forward to working closely with the FDA to complete its review and to bringing our innovative new treatment option to migraine patients in 2013."

About the Migraine Patch (NP101 or Zelrix)

NP101 is an active, single-use, transdermal patch in development for the treatment of migraine. If approved, it will be the first transdermal patch for the treatment of migraine. The patch actively delivers sumatriptan, the most widely prescribed migraine medication. In three clinical trials involving more than 10,000 applications, NP101 offered patients fast onset and sustained relief of debilitating migraine symptoms including headache pain and migraine-related nausea (MRN). Because NP101 delivers sumatriptan transdermally, it may be an attractive treatment option for many frequent MRN sufferers and those patients who experience gastroparesis, a slowing of gastric absorption. The patch utilizes SmartRelief™, NuPathe's proprietary transdermal delivery technology that allows the rapid yet tightly controlled transport of medication through the skin using a process called iontophoresis. As a result, in NP101 clinical trials there was a low incidence of triptan sensations that include chest tightness, flushing and feelings of pressure and numbness.

About Migraine and Migraine-Related Nausea

Migraine is a neurological disorder that affects approximately 30 million adults in the U.S. In addition to a headache pain, most migraine patients suffer from one or more significant gastrointestinal problems, including nausea, vomiting, and gastroparesis. Approximately eight million diagnosed migraine sufferers experience MRN in greater than fifty percent of their migraines. These frequent-MRN sufferers are less likely to achieve headache relief with oral triptans and are less satisfied with their current migraine medications. They experience more medication-related interference in several aspects of life, including their ability to work and spend time with family. In addition, these patients generate increased direct medical costs as a result of their five-fold increase in emergency room and urgent care visits and eight-fold increase in overnight hospital stay costs. Some migraine patients also experience gastroparesis, which may affect a patient's response to oral medications.