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Indivor's Opioid Use Disorder Drug Meets Primary Endpoint
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Indivior PLC announced that a pivotal study (RB-US-13-0001) evaluating its candidate, RBP-6000, in patients with moderate-to-severe opioid use disorder (OUD) met its primary endpoint. The product is administered once a month by injecting buprenorphine in the ATRIGEL delivery system. The data was presented at the Annual Scientific Meeting of the College on Problems of Drug Dependence, Montreal.
Shares of the company were up 2.77% at yesterday’s close. In fact, the stock has returned 15.4% so far this year, outperforming the Zacks classified Medical – Drugs industry which has increased 7.9% in the same period.
The phase III study evaluated two different dosages of RBP-6000 in comparison to a placebo over a period of 24-weeks in OUD patients who were not receiving any medication-assisted treatment for the assessment of mean percentage abstinence (opioid-free weeks). The patients were administered either a dose of 300mg a month for six months (300/300 mg) or a once monthly 300mg dose for two months followed by a 100mg dose a month for four months (300/100 mg).
The data showed that for both the dosage regimens of the candidate, abstinence rates were significantly higher versus placebo. The 300/300 mg regimen achieved abstinence rates of 41.3% and the 300/100 mg achieved 42.7% whereas the rates were 5% for placebo. The study also met its secondary endpoint of more than 80% urine samples of a patient negative for opioids in nearly 30% of patients for both dosage regimens.
In May 2017, Indivor submitted a new drug application (NDA) to the FDA for the approval of RBP-6000 as part of its complete treatment plan to include counseling and psychosocial support to treat opioid addiction.
The company already has an approved drug, Suboxone for the treatment of opioid dependence and upon approval RBP-6000 will boost its portfolio.
Per the press release, the national survey on Drug Use and Health in 2015 showed that 11.5 million American adults are misusing prescription pain relievers, including opioids, in the last month. Nearly 1.9 million adults in the U.S. met the criteria for prescription pain reliever use disorder in the last one year.
Regeneron’s earnings estimates moved up from $10.16 to $10.52 for 2017 and from $10.90 to $12.10 for 2018, over the last 60 days. The company delivered a positive earnings surprise in two of the last four quarters, with an average beat of 0.45%.
VIVUS’ loss estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company came up with a positive earnings surprise in three of the four trailing quarters with an average beat of 233.69%.
MEI Pharma‘s estimates changed from a loss 1 cent to a gain of 1 cent for 2017 while for 2018 the loss estimates narrowed from $1.39 to $1.38, over the last 60 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 66.56%.
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Indivor's Opioid Use Disorder Drug Meets Primary Endpoint
Indivior PLC announced that a pivotal study (RB-US-13-0001) evaluating its candidate, RBP-6000, in patients with moderate-to-severe opioid use disorder (OUD) met its primary endpoint. The product is administered once a month by injecting buprenorphine in the ATRIGEL delivery system. The data was presented at the Annual Scientific Meeting of the College on Problems of Drug Dependence, Montreal.
Shares of the company were up 2.77% at yesterday’s close. In fact, the stock has returned 15.4% so far this year, outperforming the Zacks classified Medical – Drugs industry which has increased 7.9% in the same period.
The phase III study evaluated two different dosages of RBP-6000 in comparison to a placebo over a period of 24-weeks in OUD patients who were not receiving any medication-assisted treatment for the assessment of mean percentage abstinence (opioid-free weeks). The patients were administered either a dose of 300mg a month for six months (300/300 mg) or a once monthly 300mg dose for two months followed by a 100mg dose a month for four months (300/100 mg).
The data showed that for both the dosage regimens of the candidate, abstinence rates were significantly higher versus placebo. The 300/300 mg regimen achieved abstinence rates of 41.3% and the 300/100 mg achieved 42.7% whereas the rates were 5% for placebo. The study also met its secondary endpoint of more than 80% urine samples of a patient negative for opioids in nearly 30% of patients for both dosage regimens.
In May 2017, Indivor submitted a new drug application (NDA) to the FDA for the approval of RBP-6000 as part of its complete treatment plan to include counseling and psychosocial support to treat opioid addiction.
The company already has an approved drug, Suboxone for the treatment of opioid dependence and upon approval RBP-6000 will boost its portfolio.
Per the press release, the national survey on Drug Use and Health in 2015 showed that 11.5 million American adults are misusing prescription pain relievers, including opioids, in the last month. Nearly 1.9 million adults in the U.S. met the criteria for prescription pain reliever use disorder in the last one year.
Indivior PLC Price
Indivior PLC Price | Indivior PLC Quote
Zacks Rank & Key Picks
Indivor sports a Zacks Rank #1 (Strong Buy). Some other top-ranked stocks in the health care sector include Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , VIVUS, Inc. and MEI Pharma, Inc. (MEIP - Free Report) . All the three companies carry a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates moved up from $10.16 to $10.52 for 2017 and from $10.90 to $12.10 for 2018, over the last 60 days. The company delivered a positive earnings surprise in two of the last four quarters, with an average beat of 0.45%.
VIVUS’ loss estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company came up with a positive earnings surprise in three of the four trailing quarters with an average beat of 233.69%.
MEI Pharma‘s estimates changed from a loss 1 cent to a gain of 1 cent for 2017 while for 2018 the loss estimates narrowed from $1.39 to $1.38, over the last 60 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 66.56%.
Looking for Ideas with Even Greater Upside?
Today's investment ideas are short-term, directly based on our proven 1 to 3 month indicator. In addition, I invite you to consider our long-term opportunities. These rare trades look to start fast with strong Zacks Ranks, but carry through with double and triple-digit profit potential. Starting now, you can look inside our home run, value, and stocks under $10 portfolios, plus more. Click here for a peek at this private information >>