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NEW YORK — Providing another option for people addicted to painkillers, Orexo U.S. Inc. has released Zubsolv sublingual tablets to U.S. pharmacies.
The company said Monday that the launch of Zubsolv (buprenorphine and naloxone, CIII) follows Food and Drug Administration approval of the medication, which dissolves under the tongue, in July.
Indicated for the maintenance treatment of opioid dependence, Zubsolv is intended to be used as part of a comprehensive treatment plan that includes counseling and psychosocial support.
Orexo pointed out that the higher bioavailability of Zubsolv enables the administration of a lower dose of buprenorphine, which in combination with the naloxone component reduces the amount of available drug as well as the likelihood of potential misuse and diversion.
In addition, the company said, Zubsolv is the only opioid dependence treatment available today in the highest level of child-resistant packaging (F1). Each Zubsolv tablet comes in individual unit-dose blister packages.
"Orexo is committed to advance the treatment for patients suffering from opioid dependence. Zubsolv was specifically designed to address many of the unmet needs expressed by patients being treated for opioid dependence," stated Robert DeLuca, president of Orexo U.S. "In an open-label, crossover study in 28 subjects, we found that 96% preferred the menthol taste of Zubsolv over the most commonly prescribed formulation of buprenorphine/naloxone."
Along with the commercial launch of Zubsolv, Orexo has kicked off the Time and Taste Challenge, inviting patients and prescribers to register to receive demonstration placebo tablets to experience the taste and dissolve time for the new advanced formulation of the medication.
Orexo also has introduced RISE, a 24/7, real-time, customizable support program for patients in recovery. The HIPPA-compliant program provides information about opioid dependence and resources to foster interaction between patients and their mentor network, which may also include their doctor and counselor. The program is mobile-enabled, allowing for anytime, anywhere access.
A chronic relapsing disorder that can develop from legitimate use or misuse of controlled substances, opioid dependence takes a big toll on the U.S. economy, with about $56 billion spent on the condition per year, according to a study cited by Orexo. The average health care cost per opioid-dependent patient is eight times higher. Almost 17,000 people die from opioid pain relievers in the United States each year.
