FDA rejects Insys’ opioid spray Buvaya

The US Food and Drug Administration (FDA) has sent a complete response letter to Insys Therapeutics rejecting its new drug application for Buvaya, a sublingual spray form of buprenorphine, an opioid analgesic.

This official decision follows a joint meeting of the FDA’s Anaesthetic and Analgesic Drug Products advisory committee and Drug Safety and Risk Management advisory committee which voted 18 to one against approval in May.

The committees ruled that although Insys’ clinical development programme demonstrated that all three doses of the Buvaya were statistically significant compared to the placebo, they had serious concerns about safety and side effects.

In a pivotal trial, the shortest median time to pain relief for the highest dose was 92 mins. The FDA was concerned that this delay could cause patients to unintentionally misuse the drug and suffer an overdose as they make take another dose of Buvaya or another opioid to relieve the pain quicker.

The committee minutes from the May meeting stated: "Overall, the committee agreed that the efficacy findings were not sufficient, because of the delayed time to onset of analgesia, to support the indication of ‘management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate."

Moreover, the side effects of the drug included potentially fatal hypoxia (oxygen deficiency), as well as nausea and vomiting, which could lead to more pain and poor compliance. Patients taking Buvaya had double the rate of nausea and four times the rate of vomiting than other pain relief medication.

Insys responded by saying that Buvaya could reduce the risk of addiction, overdose and death compared to other opioids and that buprenorphine was not known to be used recreationally.

The company stated that it would continue to research the ability of its buprenorphine spray to relieve pain effectively. Insys senior vice-president of regulatory affairs Steve Sherman said: "Given the attributes of our proprietary buprenorphine formulation for sublingual delivery, we continue to believe that this drug-device combination could bring value to the management of pain and will assess the next steps in the context of the company’s overall mission."

This bad news comes after accusations that Insys has been bribing doctors to prescribe its Subys (fentanyl sublingual spray). The company’s founder and majority owner John Kapoor was arrested in October 2017 on racketeering and conspiracy charges. In March, five doctors were indicted by prosecutors for conspiring to receive bribes and kickbacks from the company. The US Department of Justice jointed the five lawsuits against Insys.

This official decision follows a joint meeting of the FDA’s Anaesthetic and Analgesic Drug Products advisory committee and Drug Safety and Risk Management advisory committee which voted 18 to one against approval in May.

The committees ruled that although Insys’ clinical development programme demonstrated that all three doses of the Buvaya were statistically significant compared to the placebo, they had serious concerns about safety and side effects.

In a pivotal trial, the shortest median time to pain relief for the highest dose was 92 mins. The FDA was concerned that this delay could cause patients to unintentionally misuse the drug and suffer an overdose as they make take another dose of Buvaya or another opioid to relieve the pain quicker.

The committee minutes from the May meeting stated: "Overall, the committee agreed that the efficacy findings were not sufficient, because of the delayed time to onset of analgesia, to support the indication of ‘management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate."

Moreover, the side effects of the drug included potentially fatal hypoxia (oxygen deficiency), as well as nausea and vomiting, which could lead to more pain and poor compliance. Patients taking Buvaya had double the rate of nausea and four times the rate of vomiting than other pain relief medication.

Insys responded by saying that Buvaya could reduce the risk of addiction, overdose and death compared to other opioids and that buprenorphine was not known to be used recreationally.

The company stated that it would continue to research the ability of its buprenorphine spray to relieve pain effectively. Insys senior vice-president of regulatory affairs Steve Sherman said: "Given the attributes of our proprietary buprenorphine formulation for sublingual delivery, we continue to believe that this drug-device combination could bring value to the management of pain and will assess the next steps in the context of the company’s overall mission."

This bad news comes after accusations that Insys has been bribing doctors to prescribe its Subys (fentanyl sublingual spray). The company’s founder and majority owner John Kapoor was arrested in October 2017 on racketeering and conspiracy charges. In March, five doctors were indicted by prosecutors for conspiring to receive bribes and kickbacks from the company. The US Department of Justice jointed the five lawsuits against Insys.

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