ARX-04 Research Paper
ARX-04 is partly funded by the US Army Medical Research and Materiel Command (USAMRMC), and consists of 30 mcg sufentanil tablets delivered via a disposable, pre-filled, single-dose applicator (SDA). The drug is being developed to treat pain in a variety of settings, including the emergency room, outpatient or ambulatory surgery, non-surgical patients experiencing pain in the hospital, and post-operative patients following short-stay surgery.
Primary investigator of the ARX-04 studies, Dr. James Miner, highlighted the drug’s value proposition in AcelRx’s most recent data release, noting “in my clinical experience in a high-capacity emergency department, I believe a product with the ability to mitigate pain rapidly, without the practical …show more content…
If the advantages highlighted by Dr. Miner are a reality, and ARX-04 can capture a portion of those 51 million annual ER visits, the drug will be a major revenue driver for the company over the next few years. Our interview will take an in depth look at ARX-04’s safety and efficacy profile through their most recent Phase III data. Our members hope to gain insight into the expert’s view on the drug’s chances of approval with regulatory processes starting later this year. If the expert shows confidence in the drug’s ability to win a decent market share, AcelRx could be a major mover in 2016. Here are some questions I’d like to ask.
Questions for an Emergency Physician/Trauma Specialist with significant knowledge of different treatment options for moderate to severe acute pain, as well as AcelRx’s recent data. He or she will have experience treating patients and an understanding of regulatory processes.
How many sufferers are identified and realistically seeking treatment in your practice today, and how do you treat them?
What are the characteristics that make someone seek treatment? How many patients do you think there are in the U.S? Outside of the …show more content…
The drug is used for the treatment of adults with moderate-to-severe acute pain associated with trauma or injury in the emergency room. How much of the market for acute pain management does this group represent? Will ARX-04 only be used for this group or could it potentially be used for other patients with acute pain?
Patients receiving one dose of ARX-04 experienced an average decrease from baseline of 2.7 on a 0-10 numeric pain intensity rating scale one hour after dosing. The results were consistent with previous studies of ARX-04 in the postoperative setting. Was this result statistically significant? Can you discuss the implications of this finding?
An extension study, expected to commence by the end of March, will assess multiple doses of ARX-04, administered hourly for up to four hours (four doses). What potential issues could arise in this trial? Can you discuss the implications of this trial on ARX-04's chances of approval?
Given the current data, what are the chances of approval for ARX-04?
Assuming it gets approved, what percentage of new patients will be prescribed ARX-04? What percentage of existing patients will switch to
Primary investigator of the ARX-04 studies, Dr. James Miner, highlighted the drug’s value proposition in AcelRx’s most recent data release, noting “in my clinical experience in a high-capacity emergency department, I believe a product with the ability to mitigate pain rapidly, without the practical …show more content…
If the advantages highlighted by Dr. Miner are a reality, and ARX-04 can capture a portion of those 51 million annual ER visits, the drug will be a major revenue driver for the company over the next few years. Our interview will take an in depth look at ARX-04’s safety and efficacy profile through their most recent Phase III data. Our members hope to gain insight into the expert’s view on the drug’s chances of approval with regulatory processes starting later this year. If the expert shows confidence in the drug’s ability to win a decent market share, AcelRx could be a major mover in 2016. Here are some questions I’d like to ask.
Questions for an Emergency Physician/Trauma Specialist with significant knowledge of different treatment options for moderate to severe acute pain, as well as AcelRx’s recent data. He or she will have experience treating patients and an understanding of regulatory processes.
How many sufferers are identified and realistically seeking treatment in your practice today, and how do you treat them?
What are the characteristics that make someone seek treatment? How many patients do you think there are in the U.S? Outside of the …show more content…
The drug is used for the treatment of adults with moderate-to-severe acute pain associated with trauma or injury in the emergency room. How much of the market for acute pain management does this group represent? Will ARX-04 only be used for this group or could it potentially be used for other patients with acute pain?
Patients receiving one dose of ARX-04 experienced an average decrease from baseline of 2.7 on a 0-10 numeric pain intensity rating scale one hour after dosing. The results were consistent with previous studies of ARX-04 in the postoperative setting. Was this result statistically significant? Can you discuss the implications of this finding?
An extension study, expected to commence by the end of March, will assess multiple doses of ARX-04, administered hourly for up to four hours (four doses). What potential issues could arise in this trial? Can you discuss the implications of this trial on ARX-04's chances of approval?
Given the current data, what are the chances of approval for ARX-04?
Assuming it gets approved, what percentage of new patients will be prescribed ARX-04? What percentage of existing patients will switch to