Depomed Announces the Launch of Lazanda® (fentanyl) Nasal Spray and the Signature Support™ Program for Patients with Breakthrough Cancer Pain
Signature Support™ Program offers a full-range of services to simplify coverage support and patient assistance for patients taking Lazanda
NEWARK, Calif., Oct. 28, 2013 /PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) today announced that it has launched Lazanda® (fentanyl) nasal spray with its newly formed dedicated team of regional sales specialists and the new Signature™ Support Program. Lazanda is indicated for the management of breakthrough pain in cancer patients (BTPc) 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
"Breakthrough pain is very common among cancer patients, and can be properly managed to reduce the number and severity of episodes and the interference of daily activities," said Dr. Emil Annabi, Director of Pain Management and Assistant Professor of Anesthesiology at the University of Arizona, Tucson. "Studies show that breakthrough pain is associated with poorer function and higher cost of care, which is why cancer patients need support services so they can focus on getting pain relief and not be troubled by reimbursement and access issues."
Depomed's new Signature Support Program is designed to streamline patient access to Lazanda. Enrollment in the program is simple and easy for patients. The service provides one-on-one support for healthcare professionals and their patients by offering several services, including:
- Benefit verification and prior authorization facilitation
- Reimbursement assistance with co-pay support
- Eligibility for up to one-month free trial of Lazanda
- 1-800 reimbursement support hotline
- Monthly patient prescription reminders
"We recognize that patients with breakthrough cancer pain face many challenges, including reimbursement and access issues," said Jim Schoeneck President and CEO of Depomed, Inc "With the new Signature Support Program, patients can take advantage of a variety of coordinated resources to make sure the process of starting on Lazanda is as simple as possible."
Lazanda (fentanyl) nasal spray is a prescription medicine used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Lazanda is a Schedule 2 controlled substance and uses the patented PecSys® drug delivery system. Lazanda delivers fentanyl in a rapid, but controlled manner and is designed to deliver a fine mist spray to the nasal membrane. Each spray of Lazanda forms a gel when it contacts the nasal mucosa. The active ingredient is then rapidly absorbed across the mucus membrane and directly into the blood stream.
Important Safety Information
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL
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.
Lazanda must be kept out of reach of children.
The concomitant use of Lazanda with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.
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 not substitute a Lazanda prescription for other fentanyl products.
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. Further information is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483.
Lazanda should not be used unless the patient is regularly taking another opioid pain medicine around-the-clock for cancer pain and the patient is used to these medicines (this means that the patient is opioid tolerant). Lazanda should be kept in a safe place, away from children. Patients should get emergency help right away if: a child takes Lazanda (Lazanda can cause an overdose and death in any child who takes it), an adult who has not been prescribed Lazanda takes it or an adult who is not already taking opioids around-the-clock takes Lazanda. These are medical emergencies that can cause death.
Prescription Lazanda should be used exactly as prescribed. For additional important safety information about Lazanda, see the FDA-approved medication guide or the full prescribing information available at www.lazanda.com.
Depomed, Inc. is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia. Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults. Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Gralise and other products and product candidates are formulated with Depomed's proven, proprietary Acuform® drug delivery technology. Additional information about Depomed may be found at www.depomed.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to Depomed's ability to commercialize Lazanda, and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2012 and the Quarterly Report on Form 10-Q for the quarter ended June 30, 2013. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
August J Moretti
SOURCE Depomed, Inc.
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