FDA Approves Horizant for Postherpetic Neuralgia
GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia
LONDON & RESEARCH TRIANGLE PARK, N.C. & SANTA CLARA, Calif.--(BUSINESS WIRE)--Jun 7, 2012 - GlaxoSmithKline plc and XenoPort, Inc. announced today that the United States (US) Food and Drug Administration (FDA) has approved Horizant (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults.
The efficacy and safety of Horizant for the management of PHN was evaluated in a single 12-week principal efficacy trial, plus two supportive studies that all met their respective primary endpoints. The three clinical studies involved 574 adult patients from the US, Canada and Germany.
The recommended dosage for the management of PHN in adults is 600 mg twice daily. Treatment should be initiated at a dose of 600 mg in the morning for three days followed by 600 mg twice daily (1,200 mg/day) beginning on day four. Doses must be adjusted in patients with impaired renal function. In the 12-week, controlled study in patients with PHN, somnolence and dizziness were the most frequently reported side effects. Somnolence was reported in 10% of patients treated with 1,200 mg of Horizant per day compared with 8% of patients receiving placebo. Dizziness was reported in 17% of patients receiving 1,200 mg of Horizant per day compared with 15% of patients receiving placebo.
In association with GSK's first commercial sale of the product after approval for PHN, XenoPort is entitled to a milestone payment of $10 million from GSK.
Horizant is not approved or licensed outside the US for PHN. It was approved for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults in the US on 6th April 2011. It is not recommended for RLS patients who need to sleep during the day and remain awake at night. Please see Important Safety Information below and the complete prescribing information available at www.gsk.com.
Discovered and developed by XenoPort, gabapentin enacarbil utilizes the body's nutrient transport mechanisms that are believed to facilitate its absorption into the body. Once absorbed, it is converted into gabapentin, which binds to a specific type of calcium channel but does not exhibit affinity for other common receptors. The exact mechanism of action of the compound in treating RLS or managing the symptoms of PHN is unknown.
Horizant is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles. The same dose of Horizant results in different plasma concentrations of gabapentin relative to the same dose of other gabapentin products.
Important Safety Information for Horizant (gabapentin enacarbil)
Effects on Driving
- Horizant causes significant driving impairment. Patients on Horizant should not drive until they have sufficient experience to know whether their ability to drive is impaired. The patients' ability to assess their driving competence and their ability to assess the degree of somnolence caused by Horizant can be imperfect.
Somnolence/Sedation and Dizziness
- Horizant causes somnolence/sedation and dizziness. Patients should not drive or operate other complex machinery until they have sufficient experience on Horizant to know whether their ability to perform these tasks is impaired.
Lack of Interchangeability With Gabapentin
- Horizant is not interchangeable with other gabapentin products due to differing pharmacokinetic profiles. The same dose of Horizant results in different plasma concentrations of gabapentin relative to other gabapentin products. The safety and effectiveness of Horizant in patients with epilepsy have not been studied.
Suicidal Behavior and Ideation
- Horizant is a prodrug of
gabapentin, an antiepileptic drug (AED). AEDs increase the risk of
suicidal thoughts or behavior in patients taking these drugs for
any indication. As a prodrug of gabapentin, Horizant also
increases this risk. Patients treated with any AED for any
indication should be monitored for new or worsening depression,
suicidal thoughts or behavior, and/or any unusual changes in mood
or behavior. Anyone considering prescribing Horizant must
balance the risk of suicidal thoughts or behavior with the risk of
Patients, caregivers, and families should be informed that Horizant increases the risk of suicidal thoughts and behavior and should be advised of the need to be alert for new or worsening signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. Behaviors of concern should be reported immediately to healthcare providers.
Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including gabapentin. Horizant is a prodrug of gabapentin. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved.
Discontinuation of Horizant
- In patients with PHN receiving Horizant twice daily, reduce the dose to once daily for one week prior to discontinuation to minimize potential for withdrawal seizure.
- The most common adverse reactions for Horizant 1200 mg/day and placebo, respectively, in the PHN principal efficacy study were dizziness (17% and 15%), somnolence (10% and 8%), headache (10% and 9%), nausea (8% and 5%), and fatigue/asthenia (6% and 1%).
About Postherpetic Neuralgia
Postherpetic neuralgia is a neuropathic (nerve) pain syndrome that may result in disability in some people. PHN follows the healing of an outbreak of herpes zoster, commonly known as shingles. Approximately one million people in the US develop shingles each year. Of these, approximately ten percent develop PHN.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
XenoPort is a biopharmaceutical company focused on developing and commercializing a portfolio of internally discovered product candidates for the potential treatment of neurological disorders. Horizant is XenoPort's first FDA-approved product. GSK holds commercialization rights and certain development rights for Horizant in the US. Regnite® (gabapentin enacarbil) Extended-Release Tablets is approved for the treatment of RLS in Japan. Astellas Pharma Inc. holds all development and commercialization rights for Regnite in Japan and five other Asian countries. XenoPort holds all other world-wide rights and has co-promotion and certain development rights to gabapentin enacarbil in the US. XenoPort's pipeline of product candidates includes potential treatments for patients with spasticity and Parkinson's disease. To learn more about XenoPort, please visit the Web site at www.XenoPort.com.
Horizant is a registered US trademark of GSK. XENOPORT is a registered trademark of XenoPort, Inc. Regnite is a registered trademark of Astellas.
regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2011.
|Registered in England
980 Great West Road
Contact: GlaxoSmithKline Enquiries:
UK Media enquiries:
David Mawdsley, +44 (0) 20 8047 5502 (London)
Stephen Rea, +44 (0) 20 8047 5502 (London)
Sarah Spencer, +44 (0) 20 8047 5502 (London)
David Daley, +44 (0) 20 8047 5502 (London)
US Media enquiries:
Bradd Pavur, +1-919-483-0044 (North Carolina)
Holly Russell, +1-919-483-2954 (North Carolina)
Sally Ferguson, +44 (0) 20 8047 5543 (London)
Tom Curry, + 1-215-751-5419 (Philadelphia)
Gary Davies, + 44 (0) 20 8047 5503 (London)
Jeff McLaughlin, + 1-215-751-7002 (Philadelphia)
Ziba Shamsi, + 44 (0) 20 8047 3289 (London)
XenoPort Analyst/Investor and Media enquiries:
Jackie Cossmon, + 1-408-616-7220
Posted: June 2012
- GlaxoSmithKline and XenoPort Receive FDA Approval for Horizant - April 6, 2011
- GlaxoSmithKline and XenoPort Respond to FDA on Horizant for RLS - November 8, 2010
- Depomed Comments on DM-1796 Pre-NDA Meeting and Horizant Complete Response Letter - February 19, 2010
- GlaxoSmithKline and XenoPort Receive FDA Complete Response Letter for Horizant (GSK1838262/XP13512) for RLS - February 18, 2010
- XenoPort Announces Extension of the Horizant PDUFA Date to February 11, 2010 - February 10, 2010
- XenoPort Announces Horizant as Brand Name for XP13512 - February 4, 2010
- XenoPort to Receive $23 Million in Milestone Payments Associated With FDA Acceptance of Solzira NDA - March 16, 2009
- GSK and XenoPort Resubmit New Drug Application for Solzira in Restless Legs Syndrome - January 9, 2009
- GSK and XenoPort Announce Plans to Withdraw and Resubmit New Drug Application Requesting Approval of Solzira for Restless Legs Syndrome - November 10, 2008
- GSK and XenoPort Announce Submission of NDA Requesting FDA Approval of Solzira for Restless Legs Syndrome - September 16, 2008