The Hospice Clinician Blog

INSYS Therapeutics has announced FDA approval of SUBSYS fentanyl sublingual spray for the treatment of breakthrough cancer pain. SUBSYS is a single-dose sublingually-administered formulation of fentanyl that joins five other rapid-acting fentanyl products already on the market (Abstral, Actiq, Fentora, Lazanda and Onsolis). INSYS Therapeutics claims SUBSYS is the only transmucosal fentanyl product to show statistically significant pain relief when measuring the sum of pain intensity difference at five minutes in a Phase 3 clinical trial of breakthrough cancer pain.

SUBSYS will be launched under the recently approved Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access Program, which we will be discussing further on the blog next week. SUBSYS is expected to be available in the early part of this year.

The US Food and Drug Administration has approved Lazanda, a fentanyl  nasal spray, for management of severe breakthrough pain in adult patients with cancer.  Fentanyl nasal spray has been available in Europe under the brand name PecFent, however, Lazanda is the first fentanyl nasal spray available in the US.    Like other fentanyl products, Lazanda, is a schedule II controlled substance and it is should not be used in patients who are opioid naïve.

The nasal spray device delivers fentanyl as a fine mist which forms a gel when it comes in contact with the nasal mucosa.  The fentanyl  is rapidly absorbed  through the mucus membrane into the systemic circulation.  Analgesic effects have been demonstrated from 5 minutes after dosing, reaching clinically meaningful levels in 10 minutes.  Phase 3, double-blind studies demonstrated superior pain relief within a significantly shorter time frame with fentanyl nasal spray than with oral immediate release morphine.  There were no comparisons with the oral-transmucosal fentanyl products (Actiq, Fentora, Onsolis) reported.

As with the other fentanyl dosage-forms, there is a potential for serious adverse reactions including, respiratory depression, circulatory depression, hypotension and shock.  More common side effects may include: nausea, vomiting, constipation, somnolence, dizziness, and rhinorrhea.

The initial dose of Lazanda for all patients is 100mcg.  If the breakthrough pain episode is not relieved, patients must wait at least 2 hours before taking another dose of Lazanda.  Do Not convert patients on a mcg per mcg basis from any other fentanyl product to Lazanda because significant differences in bioavailability exist among the various dosage-forms.   

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.

The cost of Lazanda is not been provided as of the date of this article. 

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A recently completed phase III trial has demonstrated the ability of Sativex, a cannabis extract, to reduce the severe spasticity associated with multiple sclerosis (MS). Reports indicate that Sativex was successful in reducing spasm frequency, overall spasticity scores, and sleep disturbance related to spasticity. The drug is currently approved for treatment of multiple sclerosis in Europe and Canada, but not in the U.S. In the U.K. and Spain, its use is limited to only those patients who have not responded to other medication.  

Sativex is also undergoing phase III clinical trials in the U.S. for the treatment of severe neuropathic pain and cancer pain. It is already approved in Canada for severe neuropathic pain due to multiple sclerosis (MS) and as an adjunct to opioid therapy in patients with advanced cancer. The drug is believed to act via cannabinoid receptors in the CNS and in immune cells. Activation of these receptors within the pain pathways is known to reduce pain in relevant pain models. Side effects included nausea, fatigue, and dizziness which were rated mild to moderate. There is no evidence of a euphoric effect that is associated with marijuana use. It has a unique method of administration which consists of a metered dose spray under the tongue or inside the cheek. Sativex is produced by GW pharmaceuticals of the U.K. and will be marketed in the U.S. by Novartis. We may see Sativex available for management of severe pain and MS related spasticity in the U.S. possibly as soon as next year.   

For more information on Sativex Trials CLICK HERE

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