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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 24, 2023
COLLEGIUM PHARMACEUTICAL, INC.
(Exact Name of Registrant as Specified in its Charter)
Virginia |
|
001-37372 |
|
03-0416362 |
(State or Other
Jurisdiction
of Incorporation or Organization) |
|
(Commission File Number) |
|
(IRS Employer Identification
No.) |
100 Technology Center Drive |
Suite 300 |
Stoughton, MA 02072 |
(Address of principal executive offices) (Zip Code) |
Registrant’s telephone number, including
area code: (781) 713-3699
Securities registered pursuant to Section 12(b) of the Act:
Title of
each class |
Trading Symbol(s) |
Name of each
exchange on which registered |
Common stock, par value $0.001 per share |
COLL |
The NASDAQ Global Select Market |
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01 |
Other Information. |
On August 24, 2023, Collegium Pharmaceutical, Inc. issued a press release
announcing that the U.S. Food and Drug Administration 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. A copy of
the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.
Item 9.01 |
Financial Statements and Exhibits. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: August 24, 2023 |
Collegium Pharmaceutical, Inc. |
|
|
|
|
By: |
/s/ Colleen Tupper |
|
|
Name: Colleen Tupper |
|
|
Title: Executive Vice President and Chief Financial Officer |
Exhibit 99.1
Collegium Announces Extension of Nucynta Regulatory
Exclusivity through July 2026
STOUGHTON, Mass., Aug. 24, 2023 -- 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 TABLETS
Addiction, Abuse,
and Misuse
Because 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 Depression
Serious, 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 Ingestion
Accidental 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 Depressants
Concomitant 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 Syndrome
If 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:
| · | 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 Relations
ir@collegiumpharma.com
Media Contact:
Marissa Samuels
Vice President, Corporate Communications
communications@collegiumpharma.com
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