Health and Healthcare
Why This Study May Have Saved Pain Therapeutics
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Both biotech and pharmaceutical companies have a mission to make life better for everyone through the innovation and production of drugs that can save lives. Pain Therapeutics Inc. (NASDAQ: PTIE) took a slightly different angle considering this sentiment, but ultimately with the same goal when it conducted its Human Abuse Potential Study for Remoxy.
The biopharma announced top-line results for an FDA Category 3 Human Abuse Potential Study with Remoxy Extended-Release Capsules CII. Remoxy is the leading drug candidate for Pain Therapeutics. It is specifically designed to discourage certain common methods of drug tampering and misuse.
The study surrounding Remoxy demonstrated with statistical significance that both intact and chewed Remoxy were less “liked” than immediate-release oxycodone on the two primary endpoints, Drug Liking and Drug High. The Abuse Potential study was conducted in non-dependent, recreational opioid users, as recommended by FDA guidelines.
Nearly 60 subjects completed this study, at an average age of 27 years. The study’s primary objective was to measure the abuse potential of chewed and intact 40mg Remoxy, compared to 40mg immediate-release oxycodone when taken orally.
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In simpler terms, these subjects were instructed to chew Remoxy capsules for up to five minutes, but none were able to do so considering Remoxy’s high viscosity, texture or taste. Based on these results, the key takeaway is that a majority of the subjects would opt not to abuse Remoxy.
Remi Barbier, president and CEO of Pain Therapeutics, commented on the study:
We believe results of today’s study speak to the clinical and commercial potential of Remoxy. Remoxy’s high viscosity is intended to deter injection and snorting. We believe this feature, coupled to today’s data on oral abuse, contributes to an overall assessment of abuse potential that supports a label-claim for Remoxy.
So far year to date, Pain Therapeutics shares are down about 4%, but in the past 52-weeks shares are down 62% to Monday’s closing price of $1.94.
In terms of short interest, Pain Therapeutics saw it rise to 1.79 million for the April 30 settlement date, compared to the previous reading of 1.57 million. The current reading is the third highest in the past 52 weeks but the highest reading year to date.
Shares of Pain Therapeutics rose about 79% to $3.48 just after Tuesday’s opening bell. The stock has a consensus analyst price target of $8.00 and a 52-week trading range of $1.61 to $6.22.
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