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Relief from Pain of Shingles May Soon by On Way with Horizant Approval by FDA

GSK and XenoPort get approval for valuable drug to treat postherpetic neuralgia but relief for senior victims may be delayed by contract dispute, says Reuters

Click to video -
"What is Shingles"
NIHSeniorHealth.gov

June 8, 2012 – The U.S. Food and Drug Administration has approved a drug – Horizant – that has been proven to provide relief for the nerve pain that strikes millions of senior citizens after they have been stricken with shingles. Shingles is caused by the varicella zoster virus, the same virus that causes chickenpox and is most common in people age 60 and older.

GlaxoSmithKline and XenoPort, Inc. announced today that the FDA has notified them of the approval of Horizant (gabapentin enacarbil) Extended-Release Tablets, to treat postherpetic neuralgia (PHN) in adults.

Reuters reports that “XenoPort's shares fell as much as 13 percent on concerns that a contractual dispute between Xenoport and GSK over the drug, Horizant, could now take longer to resolve, RBC Capital analyst Michael Yee said.”

“The two partners are in a legal battle after XenoPort alleged that GSK had breached a contractual obligation,” according to Reuters.

 

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The news release issue by the partners says, “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.”

Last year, on April 6, the FDA approved Horizant as a once-daily treatment for moderate-to-severe restless legs syndrome (RLS), another problem that plaques seniors. People who have RLS describe feeling pulling, itching, tingling, burning, or aching in their legs, and moving the legs temporarily relieves these feelings.

“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,” says the news release from the two companies.

The recommended dosage for the management of PHN in adults is 600 mg twice daily.

“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,” the news release states.

● About Horizant

Horizant is not approved or licensed outside the U.S. for PHN. See Important Safety Information at www.gsk.com.

Discovered and developed by XenoPort, gabapentin enacarbil utilises 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 Behaviour and Ideation

Horizant is a prodrug of gabapentin, an antiepileptic drug (AED). AEDs increase the risk of suicidal thoughts or behaviour 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 behaviour, and/or any unusual changes in mood or behaviour. Anyone considering prescribing Horizant must balance the risk of suicidal thoughts or behaviour with the risk of untreated illness.

Patients, caregivers, and families should be informed that Horizant increases the risk of suicidal thoughts and behaviour 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 behaviour, or the emergence of suicidal thoughts, behaviour, or thoughts of self-harm. Behaviours 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 minimise potential for withdrawal seizure.

    ● Adverse Reactions

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 commercialising a portfolio of internally discovered product candidates for the potential treatment of neurological disorders. Horizant is XenoPort’s first FDA-approved product. GSK holds commercialisation 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 commercialisation 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.

About Postherpetic Neuralgia (PHN)

Postherpetic neuralgia is pain that lasts for more than a month after a shingles infection occurred. The pain may last for months or years.

Causes, incidence, and risk factors

    Postherpetic neuralgia occurs when the nerves have been damaged after an outbreak of shingles. Shingles is caused by the varicella zoster virus, the same virus that causes chickenpox.

    Postherpetic neuralgia is more likely to occur in people over age 60.

Symptoms

The main symptom is pain in the area where shingles once occurred.

    The pain can range from mild to very severe. It may continue, or come and go.

    The pain is described as a deep aching, burning, stabbing, or feeling like an electric shock.

    People with this pain are very sensitive to touch or temperature changes.

    The pain lasts for months or sometimes years after the shingles infection.

Treatment

    Anticonvulsant drugs, usually used for seizures, may help with the pain of damaged nerves. Gabapentin and pregabalin are the ones most often used to treat postherpetic neuralgia.

    Skin patches with lidocaine (a numbing medicine) may also be prescribed to relieve some of the pain for a period of time.

    Pain medications are often needed. Sometimes acetaminophen or NSAIDs such as ibuprofen are enough. Many patients will need stronger, prescription drugs such as codeine, hydrocodone, or oxycodone.

    Drugs used to treat depression (antidepressants) may also help reduce pain, as well as help with sleep.

    Electrical nerve stimulators may be used for severe, long-term cases of postherpetic neuralgia.

    Some people may need help from a pain specialist.

Prevention

    A herpes zoster vaccine is available. It is different from the chickenpox vaccine that children or young adults may receive. Adults over age 50 should get the herpes zoster vaccine as part of their routine medical care.

    A single shot of the vaccine can cut the risk of getting shingles by about half. It may also help prevent postherpetic neuralgia and ophthalmic herpes.

    Because the vaccine contains a live virus, it cannot be given to people who have a weak immune system.

>> National Library of Medicine - Last reviewed: June 28, 2011.

 

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