The SEGLENTIS Risk Evaluation and Mitigation Strategy (REMS) program1

Guidance for prescribers from the FDA

The benefits of treating acute pain with opioid analgesics should always outweigh the risks of addiction, abuse, and misuse. To ensure this, healthcare providers are strongly encouraged to do all of the following:

Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain.

Discuss the safe use, serious risks, best storage practices, and proper disposal of opioid analgesics with patients and/or their caregivers every time SEGLENTIS is prescribed.

To access important documents like the Patient Counseling Guide (PCG), head to www.fda.gov/OpioidAnalgesicREMSPCG.

Emphasize to patients and/or their caregivers the importance of reading the Medication Guide that they will receive from their pharmacists every time an analgesic is dispensed to them.

Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements, that reinforce patient-prescriber responsibilities.

To obtain further information on the opioid analgesic REMS and for a list of accredited REMS Continuing Medical Education/CE, call 1-800-503-0784 or log on to www.opioidanalgesicrems.com.

The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint.

Welcome to

Crystal Clear

CRYSTAL CLEAR offers educational resources and expert insights at your fingertips. Take a closer look:

SEGLENTIS video library

Watch the videos below to hear from experts about how SEGLENTIS works to help manage patients with acute pain.

See SEGLENTIS in action

The first and only co-crystal for the management of acute pain in appropriate adults

See how SEGLENTIS leverages complementary analgesic and anti-inflammatory mechanisms of action to deliver pain relief.

Dr. Charles Argoff

4 complementary analgesic and anti-inflammatory mechanisms in 1 tablet

Explore the unique co-crystal technology elements composing SEGLENTIS.

Dr. Charles Argoff

SEGLENTIS: A multimodal approach for acute pain

Discover how the complementary mechanisms of action of SEGLENTIS provide an alternative multimodal approach for acute pain in appropriate patients.

Dr. Charles Argoff


Hear from experts about SEGLENTIS

SEGLENTIS pivotal Phase 3 study design

It’s all in the details. Learn about the study design of the SEGLENTIS pivotal Phase 3 trial and key endpoints used for evaluation.

Dr. Eugene Viscusi

Managing acute pain differently in appropriate patients

See how SEGLENTIS can help manage acute pain differently in appropriate patients by exploring the efficacy and safety data of SEGLENTIS.

Dr. Oscar de Leon-Casasola

Unique and convenient 12-hour dosing with SEGLENTIS

Dose differently with SEGLENTIS. Watch to learn about the important dosing information for SEGLENTIS, a management option for acute pain in appropriate adults.

Dr. Steven Gershon

The SEGLENTIS case files with Dr. Steven Gershon and Dr. Shawn Dhillon

Join this conversation with the experts to explore a case of acute low back pain for which SEGLENTIS may be appropriate.

Dr. Steven Gershon and Dr. Shawn Dhillon

The SEGLENTIS case files: Jordan’s acute pain story

Pain is personal. Join Dr. Steven Vacalis as he 
tackles a case of acute hip pain and find out how SEGLENTIS could be a valuable treatment option 
for appropriate patients with acute pain.

Dr. Steven Vacalis

Primary care insights into the treatment of acute pain using SEGLENTIS

Get the scoop on how primary care physicians treat acute pain and how SEGLENTIS can be a valuable treatment option for appropriate patients.

Dr. Bill McCarberg and Dr. Jayson Dupré

For acute pain in appropriate patients: Podcasts to listen to

Join us in this engaging podcast series on acute pain management.

Podcast icon

Episode 1: Bunionectomy as an acute surgical pain model

A discussion with Dr. Ira Gottlieb on the considerations of the bunionectomy model used in the SEGLENTIS clinical program.

Rewind podcast 15 seconds Play podcast Pause podcast Fast forward podcast 15 seconds

00:00/08:00

00:00/08:00

Podcast icon

Episode 2: Pain by the numbers

Discover how SEGLENTIS clinical data translate into your practice with Dr. Eugene Viscusi.

Rewind podcast 15 seconds Play podcast Pause podcast Fast forward podcast 15 seconds

00:00/08:00

00:00/08:00

Podcast icon

Episode 3: Acute pain in primary care and the role of SEGLENTIS

Tune in to hear from Dr. Stephen Brunton on treating acute pain in the primary care setting, including a case of acute knee pain, and find out if your patients with acute pain could benefit from SEGLENTIS.

Rewind podcast 15 seconds Play podcast Pause podcast Fast forward podcast 15 seconds

00:00/08:00

00:00/08:00

Podcast icon

Episode 4: CDC acute pain guideline updates

Hear from Dr. Jeffrey Gudin about the 2022 updates to the CDC Clinical Practice Guideline for Prescribing Opioids for Pain and how SEGLENTIS offers a treatment option aligned with the recent recommendations.

Rewind podcast 15 seconds Play podcast Pause podcast Fast forward podcast 15 seconds

00:00/08:00

00:00/08:00

Downloadable resources

Explore even more resources to learn about SEGLENTIS for the management of acute pain in appropriate patients.

Pain by the numbers

Download to discover what summed pain intensity difference over 48 hours (SPID48) is and how it served as the primary efficacy endpoint in the SEGLENTIS Phase 3 study.

Download

SEGLENTIS: Multimodal therapy in a single co‑crystal

Dive in for a download on the unique co-crystal technology composing SEGLENTIS and how it provides a different approach to acute pain management.

Download

Guideline at a glance

Download now to learn more about how SEGLENTIS aligns with the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain.

Download

A road map to help navigate acute pain treatment options

Download the road map to determine if your patients with acute pain are candidates for SEGLENTIS.

Download

SEGLENTIS video library

Watch the videos below to hear from experts about how SEGLENTIS works to help manage patients with acute pain.

See SEGLENTIS in action

The first and only co-crystal for the management of acute pain in appropriate adults

See how SEGLENTIS leverages complementary analgesic and anti-inflammatory mechanisms of action to deliver pain relief.

Dr. Charles Argoff

4 complementary analgesic and anti-inflammatory mechanisms in 1 tablet

Explore the unique co-crystal technology elements composing SEGLENTIS.

Dr. Charles Argoff

SEGLENTIS: A multimodal approach for acute pain

Discover how the complementary mechanisms of action of SEGLENTIS provide an alternative multimodal approach for acute pain in appropriate patients.

Dr. Charles Argoff


Hear from experts about SEGLENTIS

SEGLENTIS pivotal Phase 3 study design

It’s all in the details. Learn about the study design of the SEGLENTIS pivotal Phase 3 trial and key endpoints used for evaluation.

Dr. Eugene Viscusi

Managing acute pain differently in appropriate patients

See how SEGLENTIS can help manage acute pain differently in appropriate patients by exploring the efficacy and safety data of SEGLENTIS.

Dr. Oscar de Leon-Casasola

Unique and convenient 12-hour dosing with SEGLENTIS

Dose differently with SEGLENTIS. Watch to learn about the important dosing information for SEGLENTIS, a management option for acute pain in appropriate adults.

Dr. Steven Gershon

The SEGLENTIS case files with Dr. Steven Gershon and Dr. Shawn Dhillon

Join this conversation with the experts to explore a case of acute low back pain for which SEGLENTIS may be appropriate.

Dr. Steven Gershon and Dr. Shawn Dhillon

The SEGLENTIS case files: Jordan’s acute pain story

Pain is personal. Join Dr. Steven Vacalis as he 
tackles a case of acute hip pain and find out how SEGLENTIS could be a valuable treatment option 
for appropriate patients with acute pain.

Dr. Steven Vacalis

Primary care insights into the treatment of acute pain using SEGLENTIS

Get the scoop on how primary care physicians treat acute pain and how SEGLENTIS can be a valuable treatment option for appropriate patients.

Dr. Bill McCarberg and Dr. Jayson Dupré

For acute pain in appropriate patients: Podcasts to listen to

Join us in this engaging podcast series on acute pain management.

Podcast icon

Episode 1: Bunionectomy as an acute surgical pain model

A discussion with Dr. Ira Gottlieb on the considerations of the bunionectomy model used in the SEGLENTIS clinical program.

Rewind podcast 15 seconds Play podcast Pause podcast Fast forward podcast 15 seconds

00:00/08:00

00:00/08:00

Podcast icon

Episode 2: Pain by the numbers

Discover how SEGLENTIS clinical data translate into your practice with Dr. Eugene Viscusi.

Rewind podcast 15 seconds Play podcast Pause podcast Fast forward podcast 15 seconds

00:00/08:00

00:00/08:00

Podcast icon

Episode 3: Acute pain in primary care and the role of SEGLENTIS

Tune in to hear from Dr. Stephen Brunton on treating acute pain in the primary care setting, including a case of acute knee pain, and find out if your patients with acute pain could benefit from SEGLENTIS.

Rewind podcast 15 seconds Play podcast Pause podcast Fast forward podcast 15 seconds

00:00/08:00

00:00/08:00

Podcast icon

Episode 4: CDC acute pain guideline updates

Hear from Dr. Jeffrey Gudin about the 2022 updates to the CDC Clinical Practice Guideline for Prescribing Opioids for Pain and how SEGLENTIS offers a treatment option aligned with the recent recommendations.

Rewind podcast 15 seconds Play podcast Pause podcast Fast forward podcast 15 seconds

00:00/08:00

00:00/08:00

Downloadable resources

Explore even more resources to learn about SEGLENTIS for the management of acute pain in appropriate patients.

Pain by the numbers

Download to discover what summed pain intensity difference over 48 hours (SPID48) is and how it served as the primary efficacy endpoint in the SEGLENTIS Phase 3 study.

Download

SEGLENTIS: Multimodal therapy in a single co‑crystal

Dive in for a download on the unique co-crystal technology composing SEGLENTIS and how it provides a different approach to acute pain management.

Download

Guideline at a glance

Download now to learn more about how SEGLENTIS aligns with the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain.

Download

A road map to help navigate acute pain treatment options

Download the road map to determine if your patients with acute pain are candidates for SEGLENTIS.

Download

See how SEGLENTIS performed in a Phase 3 clinical trial

Access the full report in Pain Practice to learn more about how SEGLENTIS demonstrated analgesic efficacy over 48 hours compared to tramadol hydrochloride, celecoxib, and placebo.

Read report

The SEGLENTIS® Savings Card is Discontinued

A patient's insurance may still cover SEGLENTIS; however, effective November 1st, 2023, the co-pay support program has been discontinued.

Thank you

Reference: 1. Seglentis [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; October 2021.