Zubsolv (Buprenorphine and Naloxone) - Maintenance Treatment for Opioid Dependence, United States of America

Orexo received approval from the FDA for Zubsolv as a maintenance treatment

Zubsolv (buprenorphine and naloxone) is a sublingual tablet indicated as maintenance treatment for people suffering from opioid dependence. The drug was discovered and developed by Orexo.

Orexo submitted a new drug application (NDA) for Zubsolv to the US Food and Drug Administration (FDA) in September 2012. The NDA was accepted for FDA review in November 2012.

Orexo received approval from the FDA for Zubsolv as a maintenance treatment for opioid dependence, in July 2013. In August 2015, Zubsolv received approval from the FDA for initiation of buprenorphine maintenance therapy in patients with opioid dependence.

Opioid dependence

"Orexo submitted a new drug application (NDA) for Zubsolv to the US FDA (Food and Drug Administration) in September 2012."

Opioids are drugs that are taken either for pleasure or pain relief. Opioids block the body's ability to feel pain. Opioid dependence means inability to put an end to the use of opiates, such as heroin, hydrocodone, codeine, morphine and oxycodone.

The prolonged use of opiates has harmful consequences, such as liver problems, depressive mood and impairment of cognitive functioning.

The condition is estimated to affect about five million people in the US. It is also found that just 20% of the people suffering from opioid dependence receive treatment.

The treatment costs associated with opioid dependence in the US are approximately $55bn a year, according to the Institute of Addiction Medicine.

Zubsolv's mechanism of action

Zubsolv is made with the combination of opioid and opioid antagonist drugs, which include buprenorphine and naloxone formulations respectively. The drug works by easing the withdrawal symptoms and also blocks the high effects of opioids.

The drug is available in tablet form in 1.4mg/0.36mg and 5.7mg/1.4mg doses. It is meant for sublingual administration and dissolves under the tongue in just a few minutes.

Clinical trials on the maintenance treatment for opioid dependence

Orexo observed positive results from phase one clinical studies on Zubsolv in 2011. Commercial formulation and dosage of Zubsolv were determined during the phase one trials.

"The drug works by easing the withdrawal symptoms and also blocks the high effects of opioids."

Orexo conducted phase three clinical trials on Zubsolv, to assess acceptance of the drug in comparison with Suboxone. The study was completed in November 2012. It was a cross-over trial which enrolled 28 participants. The patients were administered with either Zubsolv or Suboxone in random orders on separate study days.

The study's results showed that Zubsolv was preferred by eight out of ten participants. The parameters for the acceptance included ease of administration, taste masking, after-taste experience and mouth-feel.

Orexo began a phase three clinical study on Zubsolv in June 2013. It is a randomised, double blind and parallel assignment. It enrolled 300 subjects with opioid dependence in the US.

The primary outcome measure of the study is the retention in treatment on day three. The secondary outcome measures included clinical opiate withdrawal scale score, subjective opiate withdrawal scale score and urine drug screens negative for opioids. The study was completed in the second quarter of 2014.

Marketing commentary for Orexo's Zubsolv

Orexo is a leading specialty pharmaceutical company with its headquarters located in Sweden. The company's commercial operations are located in the US, while research and development operations are located in Sweden. The company develops new drugs using a combination of well-documented substances.

Orexo introduced Zubsolv across the US markets in September 2013, in association with Publicis Touchpoint Solutions. The drug faced tough competition from Suboxone, which was developed by Reckitt Benckiser Pharmaceuticals that made approximately $1.3bn worth of sales in 2011.

Orexo retains the patents for the technology relating to Zubsolv in the US and international markets.

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