New formulation may offer convenience to patients
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE: PFE) announced today that the United States Food and
Drug Administration (FDA) has approved LYRICA® CR
(pregabalin) extended-release tablets CV as once-daily therapy for the
management of neuropathic pain associated with diabetic peripheral
neuropathy (pDPN) and the management of postherpetic neuralgia (PHN).
LYRICA CR did not receive approval for the management of fibromyalgia.
“LYRICA CR was developed to offer patients an effective treatment option
with the convenience of once-daily dosing,” said James M. Rusnak, MD,
PhD, Chief Development Officer, Internal Medicine, Pfizer Global Product
Development. “It provides an important option for patients and health
care providers managing these often debilitating pain conditions.”
The efficacy and safety of LYRICA CR in PHN was established in a
randomized placebo-controlled clinical trial conducted in a total of 801
patients with PHN who entered single-blind treatment with LYRICA CR. As
both pDPN and PHN are peripheral neuropathic pain conditions, the PHN
data was supportive of both the pDPN and PHN indications. The randomized
trial included a six-week single-blind, dose optimization phase followed
by a 13-week double-blind phase. In the PHN study, 73.6 percent of
patients in the LYRICA CR group achieved at least 50 percent improvement
in pain intensity compared with 54.6 percent in the placebo group.
The most common adverse reactions reported with LYRICA CR were
dizziness, somnolence, headache, fatigue, peripheral edema, nausea,
blurred vision, dry mouth and weight gain.
Please see the full prescribing information and Medication Guide for
LYRICA CR (pregabalin) extended-release tablets here.
Important Safety Information
Prescription LYRICA CR is not for everyone. Patients should tell
their doctor right away about any serious allergic reaction that causes
swelling of the face, mouth, lips, gums, tongue, throat, or neck or any
trouble breathing, rash, hives, blisters or skin redness. LYRICA CR may
cause suicidal thoughts or actions in a very small number of people.
Patients, family members or caregivers should call the doctor right away
if they notice suicidal thoughts or actions, thoughts of self harm, or
any unusual changes in mood or behavior. These changes may include new
or worsening depression, anxiety, restlessness, trouble sleeping, panic
attacks, anger, irritability, agitation, aggression, dangerous impulses
or violence, or extreme increases in activity or talking. If patients
have suicidal thoughts or actions, they should not stop LYRICA CR
without first talking to their doctor. LYRICA CR may cause swelling of
the hands, legs and feet. Some of the most common side effects of LYRICA
CR are dizziness and sleepiness. Patients should not drive or work with
machines until they know how LYRICA CR affects them. Other common side
effects are tiredness, headache, nausea, blurry vision, weight gain, and
dry mouth. Also, patients should tell their doctor right away about
muscle pain along with feeling sick and feverish, or any changes in
eyesight including blurry vision or any skin sores in patients with
diabetes. There may be a higher chance of swelling, hives or gaining
weight in patients also taking certain diabetes or high blood pressure
medicines. Patients should not drink alcohol while taking LYRICA CR.
Patients may have more dizziness and sleepiness if taking LYRICA CR with
alcohol, narcotic pain medicines, or medicines for anxiety. Patients who
have had a drug or alcohol problem may be more likely to misuse LYRICA
CR. Patients should tell their doctor if planning to father a child, if
pregnant, or planning to become pregnant. Breastfeeding is not
recommended while taking LYRICA CR. Patients should talk with their
doctor before they stop taking LYRICA CR or any other prescription
medication.
Pfizer Inc.: Working together for a healthier world®
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to people that extend and significantly improve their lives. We strive
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DISCLOSURE NOTICE: The information contained in this release
is as of October 12, 2017. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result of
new information or future events or developments. This release contains
forward-looking information about LYRICA CR, including its potential
benefits, that involves substantial risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by such statements. Risks and uncertainties include, among other
things, uncertainties regarding the commercial success of LYRICA CR; the
uncertainties inherent in research and development, including, without
limitation, the ability to meet anticipated regulatory submission dates,
as well as the possibility of unfavorable clinical trial results,
including unfavorable new clinical data and additional analyses of
existing clinical data; whether and when any applications for LYRICA CR
may be filed with regulatory authorities in any other jurisdictions;
whether and when regulatory authorities in any such other jurisdictions
may approve any such applications that may be pending or filed for
LYRICA CR, which will depend on the assessment by such regulatory
authorities of the benefit-risk profile suggested by the totality of the
efficacy and safety information submitted; decisions by regulatory
authorities regarding labeling and other matters that could affect the
availability or commercial potential of LYRICA CR; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2016 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results”, as well as in
its subsequent reports on Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at www.sec.gov
and www.pfizer.com.
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Source: Pfizer Inc.