Collegium Obtains Six Month Extension of U.S. Pediatric Exclusivity for Nucynta Franchise

Collegium Obtains Six Month Extension of U.S.

Pediatric Exclusivity for Nucynta Franchise

STOUGHTON, Mass., June 13, 2024

-- 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 pediatric exclusivity for Nucynta and Nucynta ER ("the Nucynta Franchise"). In

2023, FDA granted New Patient Population exclusivity for Nucynta in pediatrics, extending the period of U.S. exclusivity from June 27,

2025, to July 3, 2026. FDA's grant of pediatric exclusivity now extends exclusivity of the Nucynta Franchise an additional

six months, to January 3, 2027, for Nucynta and December 27, 2025, for Nucynta ER.

"We are pleased with FDA's grant of pediatric exclusivity

for the Nucynta Franchise," said Thomas Smith, M.D., Collegium's Chief Medical Officer. "This grant of pediatric exclusivity

enhances the value of the Nucynta franchise and bolsters our near-term outlook. Collegium is proud to lead with science in support of

people living with serious medical conditions and the communities we serve."

Nucynta is currently approved in the U.S. for the management of acute

pain severe enough to require an opioid analgesic, in light of the known risks associated with opioid analgesic use, and for which alternative

treatments are inadequate in adults and pediatric patients aged six years and older with a body weight of at least 40 kg.

Nucynta ER is currently approved in the U.S. for the management of

severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic, in light of the known risks

associated with opioid analgesic use, and for which alternative treatment options are inadequate, and severe and persistent neuropathic

pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic

and for which alternative treatment options are inadequate.

Please see Important Safety Information

that follows below and complete product information, including the Boxed Warning, available at www.NUCYNTA.com.

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:

IMPORTANT SAFETY INFORMATION ABOUT NUCYNTA TABLETS

Important information about NUCYNTA tablets:

Do not take NUCYNTA tablets if you have:

Before taking NUCYNTA tablets, tell your healthcare provider if

you have a history of:

Tell your healthcare provider if you:

When taking NUCYNTA tablets:

While taking NUCYNTA tablets, DO NOT:

The possible side effects of NUCYNTA tablets:

Get emergency medical help or call 911 right away if you have:

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.

NUCYNTA ER (tapentadol) INDICATIONS AND USAGE

NUCYNTA ER (tapentadol) extended-release tablets

IMPORTANT SAFETY INFORMATION ABOUT NUCYNTA ER

Important information about NUCYNTA ER:

Do not take NUCYNTA ER if you have:

Before taking NUCYNTA ER, tell your healthcare provider if you have

Tell your healthcare provider if you:

When taking NUCYNTA ER:

While taking NUCYNTA ER, DO NOT:

The possible side effects of NUCYNTA ER are:

Get emergency medical help or call 911 right away if you have:

These are not all the possible side effects

of NUCYNTA ER. Call your healthcare provider 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, accompanying this piece or at Nucynta.com/ERpi.

Speak to your healthcare provider if you have questions about Nucynta ER.

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 current and future market opportunities for our

products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not

historical facts. 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 risks relating to, among others:

unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial

performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with

licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products,

and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and

our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and

degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing

market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the

outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient

for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations

and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient

intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the

manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency, or DEA, compliance; our customer concentration; and the

accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are

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.

Christopher James, M.D.

Vice President, Investor Relations

Vice President, Corporate Communications