READING, England and BEDMINSTER, N.J., Oct. 17, 2011 /PRNewswire/ -- Archimedes Pharma Ltd., and its subsidiary, Archimedes Pharma U.S. Inc., today announced that Lazanda® (fentanyl) nasal spray is now available by prescription in U.S. pharmacies. Lazanda is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. The U.S. Food and Drug Administration approved Lazanda on June 30, 2011, marking the first product approval for Archimedes Pharma in the U.S. and the first fentanyl nasal spray in the U.S.
Breakthrough pain, experienced by more than half of patients with cancer who have pain, can be debilitating to patients and interfere with their ability to engage in daily living activities. Different from the constant background pain many patients with cancer experience, breakthrough pain is described as an intense, excruciating pain with rapid onset and relatively short duration, which occurs despite taking appropriate opioid therapy for background pain."Even though the incidence of breakthrough pain is high in cancer patients, it is often not correctly identified nor reported," said Nash Gabrail, MD, MRCP, of the Gabrail Cancer Center and clinical investigator for Lazanda. "If reported, it is typically managed by either increasing the dose of background opioids or giving an additional dose of a short-acting oral opioid – neither of which is optimal therapy. Lazanda, with its rapid and controlled availability, can provide pain relief with an onset of action and duration of effect that addresses the time course of a typical breakthrough pain episode."
Lazanda uses Archimedes' patented PecSys® drug delivery system, which allows the active ingredient to be rapidly absorbed across the nasal membrane and directly into the blood stream. Lazanda is marketed as PecFent® (fentanyl pectin nasal spray) in Europe, where it is presently available in six countries.
"As the first and only treatment option in the U.S. offering fentanyl through nasal administration, Lazanda provides clinically proven pain relief to adult cancer patients suffering from breakthrough pain," noted Jeffrey H. Buchalter, chief executive officer of Archimedes Pharma. "The availability of Lazanda also is an exciting milestone for Archimedes Pharma as it marks our first product launch in the U.S. and represents the expansion of the brand from Europe."
Lazanda will be available through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors. Under the Lazanda REMS program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to dispense, distribute, and prescribe Lazanda.
About Lazanda® (fentanyl) nasal spray Lazanda contains fentanyl, which is a Schedule II controlled substance, and uses Archimedes Pharma's patented drug delivery system, PecSys®.
Lazanda, incorporating PecSys technology, delivers fentanyl in a rapid, but controlled manner and is designed to deliver a fine mist spray to a mucus membrane, in this case 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.
The efficacy of Lazanda for the management of breakthrough pain in adult cancer patients was established in a double-blind, placebo-controlled clinical study in patients receiving opioid therapy for background pain, in which Lazanda showed a statistically significant improvement compared with placebo on the primary endpoint, the sum of the pain intensity difference at 30 minutes (SPID30). More than 500 patients evaluated in the clinical trial program (which included three phase III clinical trials) contributed to the understanding of the tolerability and safety profile of Lazanda. The most common adverse events associated with Lazanda were consistent with opioid treatment and included vomiting, nausea, pyrexia (fever), and constipation.IMPORTANT SAFETY INFORMATION WARNINGS: POTENTIAL FOR ABUSE and IMPORTANCE OF PROPER PATIENT SELECTIONLazanda® 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. Consider the potential for abuse when prescribing or dispensing Lazanda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Schedule II opioid substances, which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Serious adverse events, including deaths, in patients treated with other oral transmucosal fentanyl products have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of Lazanda for any other fentanyl product may result in fatal overdose.Lazanda is indicated only for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg of oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer. Lazanda is contraindicated in opioid non-tolerant patients and is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients treated with other fentanyl products. When prescribing, do not convert patients on a mcg per mcg basis from another fentanyl product to Lazanda. Patients beginning treatment with Lazanda must begin with titration from the 100 mcg dose. (see Dosage and Administration) When dispensing, do not substitute a Lazanda prescription for any other fentanyl product. Substantial differences exist in the pharmacokinetics of Lazanda compared to other fentanyl products that could result in clinically important differences in the rate and extent of absorption of fentanyl and could result in fatal overdose. Special care must be used when dosing with Lazanda. If the breakthrough pain episode is not relieved, patients must wait at least 2 hours before taking another dose of Lazanda. (see Dosage and Administration)Lazanda is intended to be used only in the care of opioid tolerant patients with cancer and only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.Patients and their caregivers must be instructed that Lazanda contains a medicine in an amount that can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid tolerant. Lazanda must be kept out of the reach of children at all times. (see Patient/Caregiver Instructions) The concomitant use of Lazanda with cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations and may cause potentially fatal respiratory depression.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 the Lazanda REMS® (Risk Evaluation and Mitigation Strategy) program. Under the Lazanda® REMS program, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program to prescribe, receive, dispense, and distribute Lazanda, respectively. [see Warnings and Precautions]. Further information is available at www.LazandaREMS.com or by calling 1-855-841-4234.Contraindications
Warnings And Precautions
Use In Specific Populations
Please see the accompanying full Prescribing Information including boxed warning. For more information, please visit http://www.lazanda.com/Lazanda_PI.pdf.
About Archimedes PharmaArchimedes Pharma is an international specialty pharmaceutical company providing novel and advanced treatments to address unmet needs for people living with serious or life-threatening chronic and debilitating illnesses. Archimedes Pharma markets a diverse portfolio of speciality products and has operations in the U.S. and throughout Europe. Archimedes Pharma U.S. Inc. is a subsidiary of Archimedes Pharma Ltd. For more information, please visit: www.ArchimedesPharma.com.
Lazanda®, PecFent®, and PecSys® are registered trademarks of Archimedes Development Ltd.
|SOURCE Archimedes Pharma Ltd.|
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