Our Products

Depomed is committed to becoming a leader in the clinical development and commercialization of therapies for pain management and other central nervous system (CNS) conditions. The company’s four current products, Gralise, Cambia, Zipsor, and Lazanda have established Depomed’s expertise in building effective marketing strategies and solutions-oriented sales teams. The company intends to leverage this growing domain expertise with additional CNS products. DM-1992 (for Parkinson’s Disease) is currently poised to begin phase 3 clinical trials, and the company is actively assessing other well-characterized compounds for in-licensing and development.

 

See full Prescribing Information and Medication Guide

For more information, please visit www.gralise.com.

 

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Risk

Non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.1)].

CAMBIA is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].

Gastrointestinal Risk

NSAIDs increase the risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.2)].

See full Prescribing Information including Boxed WARNING, and Medication Guide at www.CambiaRx.com for more information.

 

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Risk

Zipsor, like all nonsteroidal anti-inflammatory drugs (NSAIDs), may cause increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (Warnings and Precautions 5.1)

Zipsor is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. (Contraindications 4)

Gastrointestinal Risk

NSAIDs, including Zipsor, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach and intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (Warnings and Precautions 5.2)

See full prescribing information for complete boxed warning.

See full Prescribing Information including Boxed WARNING regarding cardiovascular and gastrointestinal risks

For more information, please visit www.zipsor.com.

 

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

RESPIRATORY DEPRESSION

Fatal respiratory depression has occurred in patients treated with immediate-release transmucosal fentanyl, including following use in opioid non-tolerant patients and improper dosing. The substitution of Lazanda for any other fentanyl product may result in fatal overdose.

Due to the risk of respiratory depression, Lazanda is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients. [see Contraindications]

Lazanda must be kept out of reach of children. [see Patient Counseling Information and How Supplied/Storage and Handling

The concomitant use of Lazanda with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see Drug Interactions]. 

MEDICATION ERRORS

Substantial differences exist in the pharmacokinetic profile of Lazanda compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.

  • When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to Lazanda.
  • When dispensing, do notsubstitute a Lazanda prescription for other fentanyl products. 

ABUSE POTENTIAL

Lazanda contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Lazanda can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Lazanda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.

Because of the risk for misuse, abuse, addiction, and overdose, Lazanda is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. [see Warnings and Precautions] Further information is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483.

See full Prescribing Information including Boxed WARNING, and Medication Guide at www.lazanda.com for more information.

 

If you have any questions regarding our marketed products, please call 1.866.458.6389.

Improving Patient Lives

In addition to its core CNS and pain therapeutics, Gralise, Cambia, Zipsor, and Lazanda, Depomed is enhancing therapeutic outcomes through the incorporation of its Acuform drug delivery technology in products marketed by the company’s strategic partners. Acuform is a proprietary gastroretentive polymer formulation that allows continuous, controlled delivery of drug compounds with one or two oral doses. Products based on Acuform may provide patients and caregivers with greater convenience, more efficient absorption, enhanced safety and increased efficacy.