Collegium Announces Extension of Nucynta Regulatory Exclusivity through July 2026
August 24 2023 - 8:00AM
Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading,
diversified specialty pharmaceutical company committed to improving
the lives of people living with serious medical conditions, today
announced that the U.S. Food and Drug Administration (FDA) has
granted New Patient Population exclusivity for Nucynta®, an
immediate release formulation of tapentadol. This grant extends the
period of U.S. exclusivity for Nucynta from June 27, 2025 to July
3, 2026.
The exclusivity determination is based on data
from pediatric trials which were submitted in response to the FDA's
Pediatric Written Request to evaluate the use of Nucynta as a
treatment for pain in pediatric patients aged 6 years and
older.
Nucynta is currently approved in the U.S. for
the management of acute pain severe enough to require an opioid
analgesic and for which alternative treatments are inadequate in
adults and pediatric patients aged 6 years and older with a body
weight of at least 40kg.
“We believe that this grant of additional
exclusivity recognizes the importance of Nucynta in the treatment
of acute, severe pain,” said Thomas Smith, M.D., Collegium’s Chief
Medical Officer. “We remain committed to the Nucynta Franchise,
including through continued pursuit of a pediatric extension which
would extend exclusivity of the entire Nucynta Franchise an
additional six months, to December 2025 for Nucynta ER and January
2027 for Nucynta.”
About Collegium Pharmaceutical,
Inc.
Collegium is a leading, diversified specialty
pharmaceutical company committed to improving the lives of people
living with serious medical conditions. Collegium’s headquarters
are located in Stoughton, Massachusetts. For more information,
please visit the Company’s website at www.collegiumpharma.com.
NUCYNTA® (tapentadol)
INDICATIONS AND USAGE
NUCYNTA® (tapentadol) tablets are:
- A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage short term (acute) pain in adults
and children 6 years of age and older who weigh at least 88 pounds
(40 kg), when other pain treatments such as non-opioid pain
medicines do not treat your pain well enough or you cannot tolerate
them.
- An opioid pain medicine that can put you at risk for overdose
and death. Even if you take your dose correctly as prescribed, you
are at risk for opioid addiction, abuse, and misuse that can lead
to death.
IMPORTANT SAFETY INFORMATION ABOUT NUCYNTA
TABLETS
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
NUCYNTA TABLETSAddiction, Abuse, and MisuseBecause
the use of NUCYNTA tablets exposes patients and other users to the
risks of opioid addiction, abuse, and misuse, which can lead to
overdose and death, assess each patient’s risk prior to prescribing
and reassess regularly for the development of these behaviors and
conditions.Life-Threatening Respiratory
DepressionSerious, life-threatening, or fatal respiratory
depression may occur with use of NUCYNTA tablets, especially during
initiation of NUCYNTA tablets or following a dose increase. To
reduce the risk of respiratory depression, proper dosing and
titration of NUCYNTA tablets are essential.Accidental
IngestionAccidental ingestion of even one dose of NUCYNTA
tablets, especially by children, can result in a fatal overdose of
tapentadol.Risks From Concomitant Use With Benzodiazepines
or Other CNS DepressantsConcomitant use of opioids with
benzodiazepines or other central nervous system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death. Reserve concomitant prescribing of
NUCYNTA tablets and benzodiazepines or other CNS depressants for
use in patients for whom alternative treatment options are
inadequate.Neonatal Opioid Withdrawal SyndromeIf
opioid use is required for an extended period of time in a pregnant
woman, advise the patient of the risk of Neonatal Opioid Withdrawal
Syndrome which may be life threatening if not recognized and
treated. Ensure that management by neonatology
experts will be available at delivery.Opioid Analgesic
Risk Evaluation and Mitigation Strategy (REMS)Healthcare
providers are strongly encouraged to complete a REMS-compliant
education program and to counsel patients and caregivers on serious
risks, safe use, and the importance of reading the Medication Guide
with each prescription. |
Important information about NUCYNTA
tablets:
- Get emergency help or call 911 right away if you take
too much NUCYNTA (overdose) tablets. When you first start
taking NUCYNTA tablets, when your dose is changed, or if you take
too much (overdose), serious or life-threatening breathing problems
that can lead to death may occur. Talk to your healthcare provider
about naloxone, a medicine for the emergency treatment of an opioid
overdose.
- Taking NUCYNTA tablets with other opioid medicines,
benzodiazepines, alcohol, or other central nervous system
depressants (including street drugs) can cause severe drowsiness,
decreased awareness, breathing problems, coma, and death.
- Never give anyone else your NUCYNTA tablets. They could die
from taking it. Selling or giving away NUCYNTA tablets is against
the law.
- Store NUCYNTA tablets securely, out of sight and reach of
children, and in a location not accessible by others, including
visitors to the home.
Do not take NUCYNTA tablets if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or
intestines.
Before taking NUCYNTA tablets, tell your healthcare
provider if you have a history of:
- head injury, seizures
- problems urinating
- abuse of street or prescription drugs, alcohol addiction,
opioid overdose or mental health problems
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
Tell your healthcare provider if you:
- notice your pain getting worse. If your pain
gets worse after you take NUCYNTA tablets, do not take more NUCYNTA
tablets without first talking to your healthcare provider. Tell
your healthcare provider if the pain that you have increases, if
you feel more sensitive to pain, or if you have new pain after
taking NUCYNTA tablets.
- are pregnant or planning to become pregnant.
Use of NUCYNTA tablets for an extended period of time during
pregnancy can cause withdrawal symptoms in your newborn baby that
could be life-threatening if not recognized and treated.
- are breastfeeding. NUCYNTA tablets pass into
breast milk and may harm your baby.
- are living in a household where there are small children or
someone who has abused street or prescription drugs.
- are taking prescription or over-the-counter medicines,
vitamins, or herbal supplements. Taking NUCYNTA tablets with
certain other medicines can cause serious side effects that could
lead to death.
When taking NUCYNTA tablets:
- Do not change your dose. Take NUCYNTA tablets exactly as
prescribed by your healthcare provider.Use the lowest dose possible
for the shortest time needed.
- For acute (short-term) pain, you may only need to take NUCYNTA
tablets for a few days. You may have some NUCYNTA tablets left over
that you did not use. See disposal information at the bottom of
this section for directions on how to safely throw away (dispose
of) your unused NUCYNTA tablets.
- Take your prescribed dose every 4-6 hours, at the same time
every day. Do not take more than your prescribed dose. If you miss
a dose, take your next dose at your usual time.
- Call your healthcare provider if the dose you are taking does
not control your pain.
- If you have been taking NUCYNTA tablets regularly, do not stop
taking NUCYNTA tablets without talking to your healthcare
provider.
- Dispose of expired, unwanted, or unused NUCYNTA Tablets by
promptly flushing down the toilet, if a drug take-back option is
not readily available. Visit www.fda.gov/drugdisposal for
additional information on disposal of unused medicines.
While taking NUCYNTA tablets, DO NOT:
- Drive or operate heavy machinery, until you know how NUCYNTA
tablets affect you. NUCYNTA tablets can make you sleepy, dizzy, or
lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines
that contain alcohol. Using products containing alcohol during
treatment with NUCYNTA tablets may cause you to overdose and
die.
The possible side effects of NUCYNTA
tablets:
- constipation, nausea, sleepiness, vomiting, tiredness,
headache, dizziness, abdominal pain. Call your healthcare provider
if you have any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you
have:
- trouble breathing, shortness of breath, fast heartbeat, chest
pain, swelling of your face, tongue, or throat, extreme drowsiness,
light-headedness when changing positions, feeling faint, agitation,
high body temperature, trouble walking, stiff muscles, or mental
changes such as confusion.
These are not all of the possible side effects of NUCYNTA
tablets. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. For
more information, go to dailymed.nlm.nih.gov.
See full Prescribing Information, including Boxed
Warning on Addiction, Abuse and Misuse and other serious risks, and
the Medication Guide accompanying this piece or at
Nucynta.com/IRpi. Speak to your healthcare provider if you have
questions about Nucynta.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. We may, in some cases, use terms such as
“predicts,” “forecasts,” “believes,” “potential,” “proposed,”
“continue,” “estimates,” “anticipates,” “expects,” “plans,”
“intends,” “may,” “could,” “might,” “should” or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. Examples of forward-looking statements
contained in this press release include, among others, statements
related to our pursuit of a pediatric extension of exclusivity for
the Nucynta franchise. Such statements are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results, performance, or achievements to differ
materially from the company's current expectations, including the
risks described under the heading "Risk Factors" in our Annual
Reports on Form 10-K and Quarterly Reports on Form 10-Q and other
filings with the SEC. Any forward-looking statements that we
make in this press release speak only as of the date of this press
release. We assume no obligation to update our forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
Investor Contact:Christopher
James, M.D.Vice President, Investor
Relationsir@collegiumpharma.com
Media Contact:Marissa
SamuelsVice President, Corporate Communications
communications@collegiumpharma.com
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