Below is a very recent study of Penthrane in the US emergency setting.
Currently Penthrane is not approved by the FDA despite numerous trials elsewhere in the world and widespread adoption but the rest of the western world's medical systems.
It has been a staple of Ambulance services in Australia for many years, an excellent safety profile, so there is no real expectation that it's use should be declined.....but this is the FDA.
MVP has fallen off most investor's radar as COVID has significantly impacted their business, for a number of different reasons (reduced trauma, difficulty executing sales and regulatory hurdles, changed distribution model
Many of those reasons could reasonably be expected to disappear in the next few months. and there are encouraging signs of increasing uptake in Europe (despite the above factors). Trials are planned for China as well.
There has been recent Director buying.
I do not currently hold
HOT OFF THE PRESS
Hot off the press: the RAMPED trial—methoxyflurane for analgesia in the emergency department
First published: 26 March 2021
Discussing:: Brichko L, Gaddam R, Roman C, et al. Rapid Administration of Methoxyflurane to Patients in the Emergency Department (RAMPED): a randomized controlled trial of methoxyflurane versus standard care. Acad Emerg Med 2021;28(2):164–171.
Associated podcast: https://www.thesgem.com/2021/02/sgem320?the?ramped?trial?its?a?gas?gas?gas/
Supervising Editor: Esther K. Choo, MD, MPH.
Pain is one of the primary reasons that patients present to the emergency department (ED).1-6 Oligoanalgesia is a significant problem and effective pain management is an important indicator of the quality of patient care.7-12 Multiple factors have been thought to contribute to oligoanalgesia including overcrowding, language barriers, age, sex, ethnicity, and insurance status.13-16 Delays in providing adequate analgesia lead to poorer patient outcomes, prolonged ED length of stay, and reduced patient satisfaction.17, 18 Previous research in Australian EDs has shown that the median time to analgesia administration can be between 40 and 70 minutes, while one study in the United States reported a mean of 116 minutes.19-21 To minimize delays, various strategies have been implemented to address the problem, including the use of novel analgesic agents that do not require intravenous access.22
Recently, there has been increased interest in using methoxyflurane (Penthrox), an inhaled nonopioid volatile anesthetic, to provide rapid short?term analgesia.23, 24 In Australia, methoxyflurane has been widely used at subanesthetic doses for analgesia in the prehospital setting since 1975. It has been used more widely recently and at low doses and has a very reassuring safety profile, with no reports of addiction or abuse related to its use.25-28 The majority of studies of methoxyflurane for pain focus on traumatic pain; this study aimed to assess its effectiveness in treatment of both traumatic and nontraumatic pain.
This is a randomized controlled trial of adult ED patients with severe pain, defined by an initial numeric rating scale (NRS) pain score of greater than or equal to 8 on an 11?point scale. Treatment arm participants were given inhaled methoxyflurane at ED triage and the comparison group received standard analgesic care, which could include acetaminophen, nonsteroidal anti?inflammatory drugs (NSAIDs), tramadol, oral oxycodone, or intravenous morphine. The primary outcome was the proportion of patients who had at least a 50% reduction in pain score at 30 minutes. Secondary outcomes included median pain score at 15, 30, 60, and 90 minutes; the proportion of patients that achieved a >2?point drop in their NRS pain score, and data pertaining to adverse effects.
The most notable limitation of this study is the open?label design. There is substantial difficulty in blinding study participants to the use of an inhaled medication (methoxyflurane) that has a particular smell and taste, but the lack of allocation concealment likely biases the results toward the intervention group. Other limitations include the selection bias of nonconsecutive patient recruitment and the exclusion criteria which removed many patients with abnormal vital signs. These abnormal vital signs could have simply been due to severe pain and thus would be an excellent group of patients to study. Finally, only 4% of patients arrived by ambulance in this study, which may not be representative of many hospitals.
Overall, 121 patients were randomized into the RAMPED study and there was no statistical difference in the primary outcome between methoxyflurane and standard analgesic care. In the methoxyflurane arm five (10%) patients had a reduction of pain score by >50% at 30 minutes compared with three (5%) in the standard care arm (p = 0.49). The administration of methoxyflurane was associated with a significant reduction in pain score at all time points and a notable secondary outcome was that the median time to rescue analgesia was longer in the methoxyflurane arm, 66 minutes compared with 46 minutes in the standard care arm (p = 0.024). There were no adverse effects attributed to the methoxyflurane.
In this study of methoxyflurane versus standard analgesic therapy in the ED, there was no difference in pain reduction at 30 minutes. However, methoxyflurane does appear to be a safe and effective additional option for analgesic at ED triage.
TOP SOCIAL MEDIA COMMENTARY
Brent Driscoll: Great rapid analgesic for procedural and visceral pain even better when used in conjunction with opiates. Great synergistic effect. Fell out of favour for a while the excitement of intranasal fentanyl took hold but back in vogue as quick effective relief in trauma while IV access and opiates are readied. The ability of the patient to concentrate and titrate their dosage (“if it hurts, keep sucking”) and that it is self?regulating? if they have too much, they drop the inhaler and nod off is a great quality control. An Australian EMS staple for decades.
Minh Le Cong @ketaminh: It's a great piece of kit imo. I have one in my car kit for roadside attendances. Easy to use and effective in kids and adults. There is environmental contamination of exhaled gas to be aware of. It's like a portable mini nitrous oxide kit.
Julie Rankin @JulieRa00539796: Regular analgesia use for msk injuries in Northern Ireland ? great quick easy effective analgesia.
Prof Tim Hardcastle @vemadoc: They use it for burn dressing changes here. Works well in kids.
Evan Schwarz @TheSchwarziee: This seems to be very popular in countries outside the US. It's nice as no IV required and can be another component of multimodal pain medication whether an opioid is necessary or not.
PAPER IN A PIC BY DR. KIRSTY CHALLEN
TWITTER POLL BY KEN MILNE
In this randomized controlled trial, methoxyflurane was an effective analgesic agent for severe pain but was no more effective than standard analgesic care at 30 minutes. If available it remains an alternative analgesic strategy to usual therapies.
CONFLICT OF INTEREST
The authors have no potential conflicts to disclose.
I don't hold MVP shares, however I note the market liked today's news because MVP's share price rose +12.21% today, making them one of today's MVPs. This is the "green whistle" company by the way (Penthrox).
Penthrox is a fast onset, non-opioid analgesic indicated for pain relief by self-administration in patients with trauma and those requiring analgesia for surgical procedures. Penthrox is now approved for sale in more than 40 countries and has been used safely and effectively for more than 40 years in Australia with more than 7.0 million units sold. There is growing interest in Penthrox being used in patients undergoing investigatory procedures, as well as operational procedures such as colonoscopy.
About Medical Developments International Ltd
MVP is an Australian company delivering emergency medical solutions dedicated to improving patient outcomes. MVP is a leader in emergency pain relief and respiratory products. The Company manufactures Penthrox®, a fast-acting trauma and emergency pain relief product. It is used in Australian Hospitals including Emergency Departments, Australian Ambulance Services, the Australian Defence Forces, Sports Medicine and for analgesia during short surgical procedures such as Dental and Cosmetic surgery as well as in other medical applications. MVP is expanding internationally and manufactures a range of worldleading Asthma respiratory devices.
Recommendation: Accumulate (downgraded from Buy), Risk Rating: High, 12-month Target Price: (AUD) $7.80 (No change).
28-Apr-2020: Penthrox is approved in Thailand
Go the Green Whistle! MVP perhaps not today's Most Valuable Player, but up +8.62% nonetheless.
The CEO, John Sharman and the Non Executive Chairman, David Williams, sold a shit tonne of shares in 2018. A former director Allan McCallum sold at the same time. I am unsure whether this was a way to introduce liquidity during a capital raising, or another reason... Still I don't like it. Shares have not been sold in in other years.???
The CEO only owns 239274 shares... David Williams, owns 14.67% of the company 9608754 or shares.
Dave Williams is in similar roles with Rate my Agent, Mobile Tyre Shop, & Polynovo. Managing Director Of Kidder Williams Capital Raisings.
John Sharman was Managing Director of CVC Ventures, Vita Life Sciences. Before then CEO at Cyclopharm.
3 other directors are also directors of Polynovo and other companies.
I have not found any reviews on Glassdoor or Seek about the culture within MVP
NPAT increased 81.8% this half year and NoPAT increased 324% between 2018 and 2019. Isn't that insane growth?
Penthrox sales increased 42%UK, Aus 18%, Europe 35% and there are more countries approving all the time.. the biggest China and the US are yet to approve but Management are ticking their boxes and once that market is cracked the share price will be justified.
A side note to the Penthrox sales point is that it raises the libido in women (not men). Which can only be a good thing.
Medical Developments has 3 divisions.
Pharmaceuticals – the sale of Penthrox® . This contributes $6652000 revenue, and is their fastest growing segment.
Medical Devices - Asthma Spacers/face masks, CPR flowmeters/masks/regulators... This contributes $4,083,000.00 revenue
Veterinery - Flow metres/masks /regulators... This contributes $160000.00 revenue.
This half year report highlights some of the sales growth rates in its various divisions.
Another way they might create value is with their new manufacturing process (Continuous Flow), which is being developed with the CSIRO. This lets them use smaller factories, lower costs and speeds up manufacturing when needed, slows it down when required, and produces a higher quality product, rather than the sandardised "batch" way of manufacturing.
Management are also directors in Polynovo (burns), Probiotec (pill and potion packaging for healthcare) and a bunch of other companies in healthcare, realestate, venture capital etc. this may create possible synergies...
When I worked out their Return on Invested Capital I honestly thought "Why bother researching further" as i thought it should be huge, not negative. Once include the huge markets yet to be tapped, the current growth rates on all of their products in all regions, and the costs that should be stripped from their balance sheets I think that their profit margins will be huge.
It does pay a dividend also... At the moment its 0.5% which is nothing to brag about....Fast forward 5 years and it could be a great dividend yeild.