Pfizer Inc. (NYSE:PFE) announced today top-line results of a
double-blind Phase 4 study evaluating the safety and efficacy of Lyrica®
(pregabalin) Capsules CV in adolescents (ages 12-17 years) with
fibromyalgia (FM). The primary endpoint of the study was not achieved as
there was not a statistically significant difference between pregabalin
and placebo in mean pain score. The treatment difference was 0.66
points, which reflects an improvement of 1.60 points from baseline for
pregabalin-treated patients and 0.94 points for placebo (p=0.121). This
study was conducted to fulfill a post-marketing commitment required by
the U.S. Food and Drug Administration (FDA) when Lyrica was approved for
the management of fibromyalgia. The safety and efficacy of pregabalin in
pediatric patients have not been established.
A total of 107 adolescent patients were enrolled in this Phase 4,
15-week double-blind, randomized, placebo-controlled study from multiple
centers across the U.S., Europe and Asia. This study is the first large
pharmacological treatment study to be completed in this study population.
"Pfizer is committed to better understanding the full clinical profile
of our approved medicines in pediatric and adolescent patients. This
study advances the understanding of this patient population," said Steve
Romano, MD, senior vice president and Head, Global Medicines Development
for the Pfizer Global Innovative Pharmaceutical business. "Lyrica has
more than 10 years of real world experience supporting the needs of
patients and remains an important treatment choice for healthcare
professionals. These results do not change the established benefit of
Lyrica for its approved indications, including fibromyalgia in adults."
Study medication was administered twice daily. Dosing started at 75
mg/day and was optimized over a 3 week period, based on tolerability and
response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day,
with the optimized dose maintained for the next 12 weeks.
The safety profile observed in this study is consistent with the known
profile for Lyrica in prior fibromyalgia studies in adults, with the
exception of mild nausea, which occurred at a higher rate in
pregabalin-treated patients. The most common adverse events in this
study in pregabalin treated patients were dizziness, nausea, headache,
increased weight and fatigue.
Full results from the study are expected to be submitted for publication
when analyses are complete.
About Lyrica
Lyrica® is currently approved for various indications in 139
countries and regions globally.
Lyrica is approved for five indications in the U.S., of which four are
in the therapeutic area of pain. These indications include neuropathic
pain associated with diabetic peripheral neuropathy, post-herpetic
neuralgia (pain after shingles), neuropathic pain associated with spinal
cord injury, fibromyalgia and partial onset seizures in adults with
epilepsy who take one or more drugs for seizures.
Lyrica’s ongoing clinical development program is focused on the
significant unmet needs of patients with certain chronic pain conditions.
Antiepileptic drugs (AEDs), including Lyrica, increase the risk of
suicidal thoughts or behavior in patients taking AEDs for any
indication. There have been post-marketing reports of angioedema and
hypersensitivity with Lyrica. Treatment with Lyrica may cause dizziness,
somnolence, dry mouth, edema and blurred vision.
Other most common adverse reactions include weight gain, constipation,
euphoric mood, balance disorder, increased appetite and thinking
abnormal (primarily difficulty with concentration/attention).
For Lyrica prescribing information in the U.S. visit www.LYRICA.com.
Important Safety Information
LYRICA is contraindicated in patients with known hypersensitivity to
pregabalin or any of its other components. Angioedema and
hypersensitivity reactions have occurred in patients receiving
pregabalin therapy.
There have been postmarketing reports of hypersensitivity in patients
shortly after initiation of treatment with LYRICA. Adverse reactions
included skin redness, blisters, hives, rash, dyspnea, and wheezing.
Discontinue LYRICA immediately in patients with these symptoms.
There have been postmarketing reports of angioedema in patients during
initial and chronic treatment with LYRICA. Specific symptoms included
swelling of the face, mouth (tongue, lips, and gums), and neck (throat
and larynx). There were reports of life-threatening angioedema with
respiratory compromise requiring emergency treatment. Discontinue LYRICA
immediately in patients with these symptoms.
Antiepileptic drugs (AEDs) including LYRICA increase the risk of
suicidal thoughts or behavior in patients taking AEDs for any
indication. Monitor patients treated with any AED for any indication for
the emergence or worsening of depression, suicidal thoughts or behavior,
and/or any unusual changes in mood or behavior. Pooled analyses showed
clinical trial patients taking an AED had approximately twice the risk
of suicidal thoughts or behavior than placebo treated patients. The
estimated incidence rate of suicidal behavior or ideation among 27,863
AED-treated patients was 0.43%, compared to 0.24% among 16,029
placebo-treated patients, representing an increase of approximately one
patient for every 530 patients treated with an AED.
The most common adverse reactions across all LYRICA clinical trials are
dizziness, somnolence, dry mouth, edema, blurred vision, weight gain,
constipation, euphoric mood, balance disorder, increased appetite, and
thinking abnormal (primarily difficulty with concentration/attention).
Inform patients taking LYRICA that dizziness and somnolence may impair
their ability to perform potentially hazardous tasks such as driving or
operating complex machinery until they have sufficient experience with
LYRICA to determine its effect on cognitive and motor function.
In controlled studies, a higher proportion of patients treated with
LYRICA reported blurred vision (7%) than did patients treated with
placebo (2%), which resolved in a majority of cases with continued
dosing. Consider more frequent assessment for patients who are already
routinely monitored for ocular conditions.
Higher frequency of weight gain and edema was observed in patients
taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise
caution when coadministering these drugs. Patients who are taking other
drugs associated with angioedema such as angiotensin converting enzyme
inhibitors (ACE- inhibitors) may be at increased risk of developing
angioedema. Exercise caution when using LYRICA in patients who have had
a previous episode of angioedema.
LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on
cognitive and gross motor functioning.
Patients with a history of drug or alcohol abuse may have a higher
chance of misuse or abuse of LYRICA.
Withdraw LYRICA gradually over a minimum of 1 week. Discontinue LYRICA
immediately in patients with symptoms of hypersensitivity or angioedema.
Patients with a creatinine clearance of 30 to 60 mL/min had a greater
incidence of discontinuation due to adverse reactions than patients with
normal creatinine clearance. Adjust the daily dose of LYRICA for
patients with reduced renal function (creatinine clearance ≤60 mL/min)
and in those undergoing hemodialysis. Administer a supplemental dose of
LYRICA immediately following every 4-hour hemodialysis treatment.
In standard, preclinical in vivo lifetime carcinogenicity studies of
LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified
in 2 different strains of mice. The clinical significance of this
finding is unknown. In clinical studies across various patient
populations comprising 6396 patient-years of exposure in patients >12
years of age, new or worsening preexisting tumors were reported in 57
patients.
Please see full LYRICA prescribing information at www.LYRICA.com.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
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more than 150 years, Pfizer has worked to make a difference for all who
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Copyright Business Wire 2015