Pfizer Inc. (NYSE: PFE) and Acura Pharmaceuticals Inc. (NASDAQ:
ACUR) announce the marketing approval from the U.S. Food and Drug
Administration (FDA) of OXECTATM (oxycodone HCl, USP) Tablets CII.
OXECTA is indicated for the management of acute and chronic
moderate to severe pain where the use of an opioid analgesic is
appropriate.
OXECTA is the first immediate-release oxycodone HCl medicine
that applies technology designed to discourage common methods of
tampering associated with opioid abuse and misuse. This
AVERSION® Technology is a unique composition of commonly used
pharmaceutical ingredients. Pfizer is licensing the technology in
OXECTA from Acura.
Opioid medications are an important treatment option for
patients with moderate to severe pain who are not adequately
managed by other pain treatments. However, abuse and misuse of
opioids is a serious public health issue that is the focus of a
number of recent United States government initiatives.
“We recognize our responsibility to physicians and patients and
remain committed to appropriate access to pain treatment and
developing medicines to potentially address this important public
health and safety issue,” said Olivier Brandicourt, Pfizer
president and general manager, Primary Care. “OXECTA will further
expand Pfizer’s presence in pain management and complements our
growing, robust portfolio of treatments and medicines in
development for pain relief, one of our strategic, high-priority
disease areas. We are pleased to bring OXECTA to patients and
physicians with our partner Acura.”
“We are excited to be partnered with Pfizer to bring OXECTA to
patients who need opioids to manage their pain,” said Robert Jones,
interim president and chief executive officer of Acura
Pharmaceuticals, Inc. ”Acura is focused on developing technologies
that are intended to potentially deter abuse and misuse.”
Important Safety
Information
OXECTA is contraindicated in patients with respiratory
depression in unmonitored settings and in the absence of
resuscitative equipment, in any patient who has or is suspected of
having paralytic ileus, in patients with acute or severe bronchial
asthma or hypercarbia, and in patients with known hypersensitivity
to oxycodone, oxycodone salts, or any components of the
product.
Respiratory depression is the primary risk of OXECTA. This is
more common in elderly or debilitated patients, in those suffering
from conditions such as COPD, severe asthma, or upper airway
obstruction, or following large initial doses of opioids given to
non-tolerant patients.
OXECTA contains oxycodone HCl, an opioid agonist and a Schedule
II controlled substance. Such drugs are sought by drug abusers and
people with addictions. OXECTA can be abused in a manner similar to
other opioids and narcotics. This should be considered when
prescribing or dispensing oxycodone HCl in situations where the
physician or pharmacist is concerned about an increased risk of
misuse or abuse. OXECTA may be abused by crushing, chewing,
snorting or injecting the product. These practices pose a
significant risk to the abuser that could result in overdose and
death. OXECTA should not be given to anyone other than the
individual for whom it was prescribed. Keep OXECTA in a locked
cabinet, drawer or medicine safe so that it will not be stolen.
There is no evidence that OXECTA has a reduced abuse liability
compared to immediate-release oxycodone.
Take each OXECTA tablet with enough water to ensure complete
swallowing immediately after placing in the mouth, and OXECTA must
be swallowed whole. As OXECTA is not amenable to crushing and
dissolution, do not use OXECTA in nasogastric, gastric or other
feeding tubes as it may cause obstruction of feeding tubes.
Patients who have not been receiving opioid analgesics should
start on OXECTA in a dosing range of 5 to 15 mg every
4 to 6 hours as needed for pain. The dose should be titrated
based upon the individual patient’s response to their first dose of
OXECTA. Patients with chronic pain may need to be dosed at the
lowest dosage level that will achieve acceptable pain relief and
tolerable adverse reactions, on an around-the-clock basis rather
than on an as needed basis. When a patient no longer needs
treatment with OXECTA after long-term use, it is important to
gradually taper OXECTA over time to prevent withdrawal
symptoms.
Patients taking OXECTA in combination with other medicines like
sedatives, anesthetics or narcotics may have serious problems such
as respiratory depression, low blood pressure, profound sedation,
or coma. Do not drink alcoholic beverages or take any medicines
containing alcohol while taking OXECTA.
Use OXECTA with caution in patients with head injuries or other
conditions that increase pressure in the brain, shock with low
blood volume, severe undiagnosed abdominal conditions, history of
seizures, severe kidney or liver disease, gall bladder disease,
Addison’s disease, hypothyroidism, enlarged prostate or other
illnesses that make urination difficult and elderly or debilitated
patients. Do not use OXECTA in patients with intestinal obstruction
especially paralytic ileus.
Patients taking OXECTA should use caution when driving a car,
operating heavy machinery or doing similar, potentially dangerous
tasks as OXECTA may impair abilities needed to drive or perform
potentially dangerous activities.
The most common adverse reactions are nausea, constipation,
vomiting, headache, itchiness, trouble sleeping, dizziness, loss of
strength/energy, and sleepiness.
Keep OXECTA out of the reach of children. If a child accidently
takes OXECTA, seek emergency medical help immediately.
For additional information on the prescribing information for
OXECTA, please call 1 (800) 776-3637.
Pfizer Inc.: Working Together for a Healthier World™
At Pfizer, we apply science and our global resources to improve
health and well-being at every stage of life. We strive to set the
standard for quality, safety and value in the discovery,
development and manufacturing of medicines for people and animals.
Our diversified global health care portfolio includes human and
animal biologic and small molecule medicines and vaccines, as well
as nutritional products and many of the world’s best-known consumer
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 the world’s leading
biopharmaceutical company, we also collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a
difference for all who rely on us.
To learn more about our commitments, please visit us
at www.pfizer.com.
About Acura Pharmaceuticals
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical
company engaged in research, development and commercialization of
product candidates intended to potentially deter abuse and misuse
utilizing its proprietary AVERSION®
and IMPEDE® technologies.
Acura will receive a $20 million milestone payment from Pfizer
based on the approval of OXECTA.
Acura Forward-Looking Statements
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995 (the “Act”). Acura
Pharmaceuticals, Inc. disclaims any intent or obligation to update
these forward-looking statements, and claim the protection of the
Safe Harbor for forward-looking statements contained in the Act.
Such forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause actual results,
performance or achievements to be materially different from any
future results, performance, or achievements expressed or implied
by such forward-looking statements. Important factors that may
cause actual results to differ materially from the forward-looking
statements are discussed in the “Risk Factors” section and other
sections of the Companies’ -6-
Annual Reports on Form 10-K for the fiscal year ended December
31, 2010, and their Quarterly Reports on Form 10-Q for the quarter
ended March 31, 2011, each of which is on file with the U.S.
Securities and Exchange Commission.
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