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
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
FDA Issues Alert on Reumofan Plus. Dietary Supplement Used for Pain Relief
Health officials in Mexico order recall based on potentially harmful pharmaceutical ingredients - June 8, 2012
Shingles, a Disease Primarily Striking Senior
Citizens, Increases Risk of Multiple Sclerosis
A virus associated with MS is varicella zoster
virus, the cause of herpes zoster (shingles) - see video on shingles - June 8, 2011
Herpes Zoster Vaccine
Associated With Lower Risk of Shingles in Most Older Adults
studies showing more than half of seniors will be protected by shot but
they are still not getting it (not covered by Medicare)
- link to video in story
Jan. 11, 2011
Family History of Shingles May Be Motivator to Get
May 19, 2008 ...
Researchers report those who do get herpes zoster, or shingles,
are much more likely than others to have a family history of the
FDA Says Senior Citizens Should Get Shingles Vaccine but Many
Docs Not Buying It
Mayo Clinic study finds two issues – cost
and perception that shingles primarily affects just those with
weakened immune systems
Dec. 18, 2007
Top 10 Stories of 2006 by Harvard Health Letter Picks Key Ones
for Senior Citizens
macular degeneration, Zostavax
for shingles make list
December 4, 2006
Shingles Vaccinations Recommended for All 60 and Over
says action needed to prevent painful disease
October 26, 2006
Zostavax Shingles Vaccine Approved for Senior Citizens
FDA says it is
for those age 60 and older who are most at risk
May 26, 2006
Senior Citizen Alerts
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
● About Horizant
Horizant is not approved or licensed outside the U.S. for
PHN. See Important Safety Information at
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
● 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
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
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.
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
● The pain lasts for months or sometimes years after the
● Anticonvulsant drugs, usually used for seizures, may help
with the pain of damaged nerves.
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
● 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.
● 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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