FDA approves Orexo’s low-dose Zubsolv to treat opioid dependence

The drug, called Zubsolv, is a formulation of buprenorphine, a semisynthetic opioid derivative of thebaine, and naloxone, an opioid overdose antidote.

The new low dose, 0.7mg/0.18 mg, Zubsolv tablets are anticipated to be available in US pharmacies early next year.

Zubsolv 0.7mg offers a 50% lower dose than any other buprenorphine/naloxone product approved in the US.

The new low dose version of Zubsolv marks the sixth dosage strength the company will offer.

The FDA originally approved Zubsolv in July 2013 in two dosages of 5.7mg/1.4mg and 1.4mg/0.36mg sublingual tablet strengths.

Since then, Orexo secured FDA approval of four additional dosage strengths. 

Orexo CEO and president Nikolaj Sørensen said: “The approval of the 0.7mg Zubsolv is another significant milestone for Orexo because it marks the completion of our pharmaceutical development plan for Zubsolv.

“The new dosage has been developed in response to physician requests to be able to tailor dosing as they taper patients and ultimately provide a lower minimally effective maintenance dose.”

Orexo noted on its website that Zubsolv should be used as part of a treatment plan, which includes counseling and psychosocial support.

Zubsolv is reported to deliver a comparable concentration of active medication to previously approved buprenorphine/naloxone sublingual tablets.

Image: Orexo GMP-laboratory. Photo: courtesy of Orexo AB.