Collegium Announces Extension of Nucynta Regulatory Exclusivity through July 2026

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

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.

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.

Christopher James, M.D.

Vice President, Investor Relations

Vice President, Corporate Communications