By John Vandermosten, CFA
Avenue Therapeutics (ATXI) hosted a moderated discussion on tramadol on June 11 which featured two key opinion leaders (KOLs) in the space. The participants were Dr. Neil Singla and Dr. Harold Minkowitz. Dr. Singla brings a long history developing analgesic medicines to the discussion. He is chair of the Analgesic Clinical Trials Special Interest Group at both the American Pain Society (APS) and the International Association for the Study of Pain (IASP). Dr. Minkowitz, is an anesthesiologist and clinical researcher serving as Director of Clinical Investigation at HD Research Corp. Both have extensive clinical trials experience in pain medication.
View Exhibit I
The first topic of interest was a discussion of trends in post-surgical pain management. Both speakers acknowledged that we are in the midst of an opioid crisis where clinicians have responded by altering their prescribing practices. The change has sparked a move towards a multi-modal approach where several analgesic medications are given in combination to decrease or eliminate the amount of opioids that are used. The medical community realizes that there is an unmet need for non-opioid pain control and is seeking alternatives. Dr. Singla cited a statistic that found 1 in 16 individuals prescribed opioids for acute pain will convert to a chronic user, highlighting the need for substitutes. This realization in light of the opioid crisis has generated a concurrent drive to reduce peri-operative opioid use which carries on into discharge and the prescriptions given in this setting.
One of the benefits of using the same analgesic both in the hospital and following discharge is that the physician will be able to assess the patient’s response to the drug while they are under observation. This routine has been used for some time in Europe where IV Tramadol is the default analgesic and is prescribed after surgery in the oral form.
There are several factors supporting rapid adoption, assuming the IV form is granted approval. While surgeons, anesthesiologists and physicians generally prescribe based on their familiarity with a medicine, there are larger societal and institutional factors in the analgesic space that are motivating providers to shift to non-opioid options when available. The precedent set in Europe, the drive toward multi-modal use, provider familiarity with oral tramadol and the anticipated active competitor data from the trial are all supportive of rapid adoption. Formulary committees are under pressure to reduce the amount of Schedule II opioids used, and this suggests that the uptake of IV tramadol will be relatively rapid in hospital and ambulatory surgery centers. The key opinion leaders felt that uptake would be fastest in orthopedics, joint surgeries and abdominal surgeries as these are some of the largest categories of procedures.
Phase III Bunionectomy Results
The KOL discussion also included a review of the Phase III data that was released in late May. Both participants were very optimistic on the data and felt it was more than sufficient to support FDA approval. The KOLs highlighted the upcoming Phase III soft tissue study which will have a comparator arm with morphine. The comparator arm is very important for making the case to providers that in addition to a lower risk of abuse, that IV tramadol has very effective pain control ability as well.
‣ Topline Readout from Phase III Bunionectomy Study – May 2018
‣ Initiate Phase III Abdominoplasty Study – 3Q:18
‣ Results from Abdominoplasty Study – 2Q:19
‣ Results from Safety Study – 2Q:19
Avenue invited two key opinion leaders with extensive experience in analgesic drug development and clinical investigation to discuss the opportunities for IV tramadol. They recognized that the opioid crisis was promoting changes in prescribing habits away from Schedule II opioids. They also identified the trend towards multi-modal approaches that in many cases has been able to substantially reduce or eliminate the use of strong opioids during and after surgery. The KOLs’ first look at investigational data was positive, both in terms of safety and efficacy. Additionally, the anticipated availability of comparator data, along with other supportive factors should drive rapid adoption of IV tramadol as a replacement for stronger opioids assuming the FDA eventually approves the product.
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By John Vandermosten, CFA