XNPT » Topics » Section 8 - Other Events

This excerpt taken from the XNPT 8-K filed Nov 9, 2009.

Section 8 – Other Events

 

Item 8.01 Other Events.

On November 6, 2009, XenoPort, Inc. and GlaxoSmithKline (“GSK”) announced that the U.S. Food and Drug Administration (the “FDA”) has extended the original Prescription Drug User Fee Act (“PDUFA”) goal date for its review of GSK’s new drug application (the “NDA”) for XP13512/GSK1838262 (gabapentin enacarbil) to February 9, 2010. The original PDUFA date for this NDA review was November 9, 2009.

The FDA determined that a Risk Evaluation and Mitigation Strategy (“REMS”) was necessary for XP13512. In response to the FDA’s request, GSK submitted a proposed REMS. The FDA accepted this submission as a solicited major amendment to the XP13512 NDA. The FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment that provides a substantial amount of new data not previously reviewed by the FDA.


This excerpt taken from the XNPT 8-K filed Oct 5, 2009.

Section 8 – Other Events

 

Item 8.01 Other Events.

On October 5, 2009, XenoPort, Inc. and GlaxoSmithKline announced top-line results from a Phase 2 clinical trial evaluating XP13512/GSK1838262 (gabapentin enacarbil) in adult patients with neuropathic pain associated with post-herpetic neuralgia (“PHN”) who have had a history of inadequate response to gabapentin doses of 1800 mg/day or higher. In this double-blind, two-period cross-over study, 3600 mg/day of XP13512 demonstrated a statistically significant improvement over 1200 mg/day of XP13512 on the primary endpoint, which was the change from baseline to the end of the treatment period in the 24-hour average pain intensity score. A greater reduction in the 24-hour average pain score was observed for the 3600 mg/day dose than for the 1200 mg/day dose (adjusted difference of -0.29; p=0.013).

This study enrolled 138 subjects diagnosed with PHN who had been experiencing pain for at least three months following healing of the herpes zoster skin rash. Subjects with a history of inadequate response to gabapentin entered a baseline period where they received a dose of 1800 mg/day of gabapentin for two weeks. Subjects (N=96) who had a 24-hour average pain score of at least four on the 11-point pain intensity rating scale were then randomized to receive either 1200 mg/day of XP13512 for the first 28-day treatment period followed by 3600 mg/day for the second 28-day treatment period, or 3600 mg/day followed by 1200 mg/day. Subjects received 2400 mg/day of XP13512 for four days in between the two treatment periods.

The only treatment-emergent adverse event occurring in greater than or equal to 5% of subjects taking XP13512 was nasopharyngitis (5%). Among the other adverse events noted in this study, dizziness and somnolence occurred at rates of 4% and 3%, respectively, and were mild in intensity. Withdrawals due to adverse events during XP13512 treatment occurred in 3% of subjects.


This excerpt taken from the XNPT 8-K filed Sep 17, 2009.

Section 8 – Other Events

 

Item 8.01 Other Events.

On September 17, 2009, XenoPort, Inc. and GlaxoSmithKline announced top-line results from a Phase 2b clinical trial evaluating the safety and efficacy of XP13512/GSK1838262 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (“PHN”) in adults. In this study, subjects were randomized to receive placebo, 1200, 2400 or 3600 mg/day of XP13512 dosed twice a day. All doses of XP13512 demonstrated statistically significant improvements over placebo on the primary endpoint, which was the change from baseline to the end of maintenance treatment in the 24-hour average pain intensity score.

This 14-week, double-blind, placebo-controlled study enrolled 376 subjects with PHN who had been experiencing pain for at least three months following healing of the herpes zoster skin rash. The pre-specified statistical analysis included adjustment for comparisons of multiple XP13512 doses to placebo. The adjusted p-values for comparison of 1200, 2400 and 3600 mg/day doses to placebo were 0.013, 0.029 and 0.002, respectively.

XP13512 was generally well tolerated at all doses in this study. The most common adverse events were dizziness (placebo 15%, 1200 mg/day 17%, 2400 mg/day 26% and 3600 mg/day 30%) and somnolence (8%, 10%, 11% and 14%, respectively). Most of these adverse events were mild or moderate in intensity. There was one serious adverse event (gastritis) in the 3600 mg/day dose group that was judged by the investigator to be related to treatment. Withdrawals due to adverse events were 13%, 6%, 15% and 18%, respectively.


This excerpt taken from the XNPT 8-K filed Sep 9, 2009.

Section 8 – Other Events

 

Item 8.01 Other Events.

On September 8, 2009, XenoPort, Inc. announced preliminary results from a Phase 2 clinical trial that evaluated the safety and tolerability of arbaclofen placarbil (“AP”), also known as XP19986, when administered without titration to patients with acute back spasms. All doses of AP were safe and generally well tolerated.

This randomized, double-blind, placebo-controlled, Phase 2 clinical trial in patients with acute moderate to severe muscle spasms in the lumbar region was conducted at 17 sites in the United States. Subjects were randomized into one of four treatment arms (placebo, 20 mg BID, 30 mg BID or 40 mg BID administered without titration; 1:1:1:1 ratio) and were treated for ten days, followed by a dose-dependent taper schedule of up to four days. Evaluations of safety, tolerability and efficacy were conducted in those subjects (n=151) who received at least one dose of study medication.

The primary objective of this study was to evaluate the safety and tolerability of AP administered without titration to patients with acute back spasms. AP was safe and generally well tolerated at all dose levels. There were no drug-related serious adverse events. Six subjects in the AP dose groups withdrew from the study due to adverse events (one in each of the 20 mg and 30 mg BID groups and four in the 40 mg BID group). The most common adverse events (reported more frequently in any AP group than in the placebo group) were somnolence, dizziness and nausea. The highest incidence of any adverse event was 19% for somnolence in the 40 mg BID group compared to 12% for the placebo group. Adverse event rates for the 20 mg BID and 30 mg BID groups were comparable to the placebo group, with the exception of dizziness for the 30 mg BID group (14% versus 5% for placebo). All adverse events were rated as mild to moderate in intensity.

Several secondary efficacy measures were assessed, including pain severity score. Efficacy measures in subjects in all treatment groups were highly variable, and no differences between AP doses and placebo on these secondary efficacy measures were observed.


This excerpt taken from the XNPT 8-K filed Jun 30, 2009.

Section 8 – Other Events

 

Item 8.01 Other Events.

On June 30, 2009, XenoPort, Inc. announced positive preliminary results from a Phase 2 clinical trial of arbaclofen placarbil (“AP”), also known as XP19986, for the treatment of patients with spasticity due to spinal cord injury (“SCI”). Doses of 20 and 30 mg of AP, given twice daily (“BID”), demonstrated statistically significant improvements compared to placebo for the primary endpoint of the study. AP was well tolerated during the trial.

This Phase 2 clinical trial was a randomized, double-blind, placebo-controlled, crossover study that enrolled 37 subjects at ten sites in the United States and Canada. Subjects with SCI between C-5 and T-12 discontinued spasticity therapy during a one-week washout period prior to a one-week placebo run-in period, at the end of which baseline assessments were conducted. Subjects had an Ashworth Scale score of at least 2 in one of six assessed muscle groups (hip abductors/adductors, knee flexors/extensors and ankle flexors/extensors) on the most affected leg. Subjects received either AP (10, 20 or 30 mg BID) or placebo in the first treatment segment of the two-segment crossover design. Each treatment segment included a titration period, followed by at least one week at the target dose, at which time efficacy assessments were performed (day 17 of each treatment segment). Each treatment segment also included a down-titration period, and there was a three-day washout between treatment segments.

The primary endpoint in this study was the difference in Ashworth Scale score during the placebo and AP treatment segments for the muscle group with the highest Ashworth Scale score at baseline. Ashworth Scale scores were determined by the investigator prior to dosing, and again two, four and six hours after the morning dose. The primary analysis used a repeated-measures analysis of variance model and included data from the 35 subjects who completed both treatment segments.

Mean maximum baseline Ashworth Scale scores were 3.2 (n=10), 3.1 (n=12) and 3.1 (n=13) for the 10, 20 and 30 mg BID AP dose cohorts, respectively. For the primary endpoint, the overall adjusted mean differences between placebo and AP over the six-hour assessment period for these cohorts were -0.17 (not significant), -0.60 (p=0.0059) and -0.88 (p=0.0007), respectively. AP treatment was associated with statistically significant differences from placebo at all time points in the 20 and 30 mg BID AP dose cohorts, indicating a treatment effect over the 12-hour dosing interval. In a secondary analysis, 20 and 30 mg BID of AP also showed a statistically significant difference from placebo in the average Ashworth Scale score for all six muscle groups.

AP was well tolerated at all dose levels. There were no withdrawals due to adverse events during the trial. The most commonly reported adverse events while on any AP dose were urinary tract infection (11% AP; 9% placebo), pain in extremity (8% AP; 0% placebo), insomnia (8% AP, 0% placebo) and nasopharyngitis (8% AP; 3% placebo). Side effects were generally mild to moderate in intensity. There were no drug-related serious adverse events.


This excerpt taken from the XNPT 8-K filed Apr 27, 2009.

Section 8 – Other Events

 

Item 8.01 Other Events.

On April 27, 2009, XenoPort, Inc. and GlaxoSmithKline announced results from a Phase 2 clinical trial of XP13512/ GSK1838262 (gabapentin enacarbil) for neuropathic pain associated with diabetic peripheral neuropathy (“DPN”) in adults. XP13512 did not demonstrate a statistically significant improvement on the primary endpoint when compared to placebo, based on the change from baseline to end of treatment on the Pain Intensity-Numerical Rating Scale (PI-NRS). The pregabalin active control arm also did not differentiate from placebo on this same endpoint. The failure of the study to demonstrate a statistically significant benefit on the primary endpoint may be a consequence of the unexpectedly high placebo response rate observed in the study.

This 14-week, double-blind, placebo-controlled study enrolled 421 patients who were diagnosed with either Type 1 or Type 2 diabetes mellitus with signs and symptoms of DPN. Patients were randomized to receive either 1200 mg/day, 2400 mg/day or 3600 mg/day of XP13512 administered in divided doses twice daily, 300 mg/day of pregabalin as an active control, administered in divided doses three times daily, or placebo.

Throughout the study, XP13512 was generally well tolerated; the two most frequently reported adverse events were dizziness and somnolence.


This excerpt taken from the XNPT 8-K filed Apr 13, 2009.

Section 8 – Other Events

 

Item 8.01 Other Events.

On April 13, 2009, XenoPort, Inc., a Delaware corporation (the “Company”), announced that it had exercised the option contained in its Development and Commercialization Agreement, dated February 7, 2009 (as amended to date), with Glaxo Group Limited, a company existing under the laws of England and Wales (“GSK”), to co-promote and share profits and losses from the potential future sales of Solzira™ (gabapentin enacarbil) Extended Release Tablets in the United States. Solzira is the subject of a new drug application (“NDA”) that is under review by the U.S. Food and Drug Administration (“FDA”) as a potential treatment for moderate-to-severe primary restless legs syndrome (“RLS”).

Assuming FDA approval of the Solzira NDA for RLS, the Company will field a U.S. sales force of between 50 and 100 representatives to promote Solzira. This sales force will be geographically distributed across the United States and will call on prescribers of drugs that treat neurological diseases.

The Company also announced changes to the terms of its right to co-detail in the United States Requip® XL™, GSK’s product for Parkinson’s disease. Previously, the Company was entitled to detail Requip XL commencing upon its exercise of the co-promotion option and ending upon the launch of Solzira. Under the revised terms, the Company has the right to commence the detailing of Requip XL around the time of the Solzira launch. The Company would be entitled to continue these detailing activities until the earlier of the launch of a generic form of Requip XL or July 1, 2011. The Company would be compensated for each detail of Requip XL completed by its sales representatives through a fee that is separate from the Solzira joint profit and loss (“P&L”) statement.

Coincident with the election of the co-promotion option, all allowable expenses and any potential future sales of Solzira will be accounted for using a joint P&L statement, and the Company will share in the resulting operating profits and losses. Prior to the launch of Solzira, cash payments to GSK representing the Company’s share of any loss will be deferred and will be repayable over a period of time following the launch.

Assuming FDA approval of the Solzira NDA for RLS, GSK would be responsible for recording the sales of Solzira in the United States. Expenses that can be charged to the joint P&L statement are the cost of goods sold and certain costs directly related to Solzira marketing and sales. All future expenses related to the development of potential indications for Solzira in addition to RLS will not be included in the joint P&L statement and will be borne fully by GSK.

The Company’s exercise of the co-promotion option and its participation in the profit share arrangement may be reversed at any time upon notice to GSK with no penalty to the Company, in which case the original royalty-based compensation structure would apply for Solzira sales in the United States.


This excerpt taken from the XNPT 8-K filed Apr 1, 2009.

Section 8 – Other Events

 

Item 8.01 Other Events.

On October 12, 2007, XenoPort, Inc., a Delaware corporation (the “Company”), entered into an exclusive licensing agreement for the development and commercialization by Xanodyne Pharmaceuticals, Inc., a Delaware corporation (“Xanodyne”), of a preclinical, non-hormonal, oral product candidate known as XP21510, discovered by the Company, for the potential treatment of women diagnosed with menorrhagia, or heavy menstrual bleeding.

Under the terms of the agreement, Xanodyne receives exclusive rights to develop and commercialize XP21510 in the United States. In exchange for these rights, the Company received up-front, non-refundable cash payments totaling $12 million. The Company has received a $1 million milestone payment to date and would be eligible to receive aggregate cash payments of up to $129 million upon the achievement of certain additional development, regulatory and commercial milestones with respect to XP21510. The agreement provides that the Company would also be eligible to receive aggregate cash payments of up to $5 million upon the achievement of certain development, regulatory and commercial milestones with respect to Xanodyne’s tranexamic acid product candidate, known as XP12B. In addition, the Company would be entitled to receive tiered double-digit royalty payments on potential future sales of XP21510, as well as escalating single-digit royalties on potential future sales of XP12B.

Xanodyne has provided the Company with written notice that Xanodyne has elected to terminate the agreement. Such termination will be effective July 22, 2009. The Company will be entitled to specified transition assistance from Xanodyne. Upon termination, all XP21510 product rights will revert to the Company.


This excerpt taken from the XNPT 8-K filed Mar 16, 2009.

Section 8 – Other Events

 

Item 8.01 Other Events.

On March 16, 2009, XenoPort, Inc. announced that the U.S. Food and Drug Administration, or FDA, has accepted for review the new drug application, or NDA, filed by GlaxoSmithKline, or GSK, for Solzira™ (gabapentin enacarbil) Extended Release Tablets in the United States as a potential treatment for moderate-to-severe primary restless legs syndrome. In accordance with XenoPort’s collaboration agreements with GSK and Astellas Pharma Inc., the FDA’s acceptance of the NDA triggers milestone payments to XenoPort of $23 million in the aggregate.


This excerpt taken from the XNPT 8-K filed Mar 3, 2009.

Section 8 – Other Events

 

Item 8.01 Other Events.

On March 2, 2009, Astellas Pharma Inc. and XenoPort, Inc. announced preliminary top-line results from a Phase 2 clinical trial of XenoPort’s most advanced product candidate, XP13512 (known as ASP8825 in the Astellas territory), for the treatment of symptoms in moderate-to-severe primary restless legs syndrome (RLS) patients. The trial was conducted by Astellas in Japan. ASP8825/XP13512 demonstrated statistically significant improvements compared to placebo on the primary endpoint of the trial and was well tolerated.

This 12-week, double-blind, placebo-controlled Phase 2 clinical trial (Study 8825-CL-0003) enrolled 474 patients who were diagnosed with RLS. Patients were treated with 600, 900 or 1200 mg of ASP8825/XP13512 or placebo, given once per day after the evening meal. The primary endpoint for the clinical trial was the change from baseline for the International RLS (IRLS) rating scale score at end of treatment.

Treatment with 1200 mg of ASP8825/XP13512 was associated with a statistically significant improvement in the primary endpoint compared to placebo. Statistically significant improvements over placebo were also observed on some secondary endpoints, including the investigator-rated clinical global impression of improvement scale (CGI-I), which achieved statistical significance for each of the 600 mg, 900 mg and 1200 mg dosing cohorts.

The most commonly reported adverse events for ASP8825/XP13512 were somnolence and dizziness, which were generally transient and mild to moderate in severity. There were no treatment-emergent serious adverse events during the study period in ASP8825/XP13512-treated subjects.


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