Breakthrough Cancer Pain

Have been looking into Breakthrough Cancer Pain a bit more and its fascinating what you find in terms of the condition, the desirable attributes of treatments, the current suite of drugs used for treatment and some of the issues with these drugs and it opens your eyes to the opportunity here.

It has all become a bit more real of course since the funding announcement last week. I was kind of marvelling at the gamble that Clendon are taking - its basically a binary outcome because if the trial wasn't a success, it would be hard for them to get their money back. Says to me they are supremely confident in what is proposed and the chances of achieving an NDA

What is Breakthrough Cancer Pain?
Breakthrough Cancer Pain (BTcP) is a sudden and transient pain episodeexperienced by cancer patients, despite their regular use of long-acting painmedication. Unlike chronic cancer pain, which is managed with baseline analgesics,BTcP is an acute flare-up that can reach peak intensity within minutes and typicallylasts from a few minutes to an hour. These episodes can be triggered by factorssuch as physical activity, emotional distress, or medical interventions, although theymay also occur without any identifiable cause. Due to the sudden and severe natureof BTcP, treatment must be rapid-acting to provide meaningful relief.

BTcP is highly prevalent among cancer patients, particularly thosewith advanced disease. Studies estimate that 60-80% of cancer patients willexperience BTcP at some point during their illness. This pain significantly impactspatients’ quality of life, disrupting daily activities and emotional well-being. As thenumber of cancer patients continues to rise globally, the demand for effective BTcPtreatments is increasing.

Market size
The total addressable market (TAM) for BTcP therapeutics is driven by theincreasing incidence of cancer worldwide and the unmet need for effective painmanagement. The global cancer burden is expected to reach 29.5 million new casesannually by 2040, with a significant portion of these patients experiencing cancerpain, including BTcP. As the number of patients requiring breakthrough painmanagement rises, so too does the demand for advanced therapies.

The cancer pain management market isprojected to grow to over $9 billion by 2028, with a compound annual growth rate(CAGR) of 7-8%. BTcP is a specific, fast-growing segment of this market due to theurgent need for rapid-acting pain relief in cancer care.

The BTcP market is estimated to beworth $1.5 billion globally, with opioid-based therapies like fentanyl dominatingcurrent treatment options. With more patients being diagnosed with advancedcancer and requiring breakthrough pain relief, the BTcP drug market is poised forcontinued expansion.

Patient
The typical BTcP patient is someone with advanced cancer who is already on long-acting opioids for chronic cancer pain. Despite using these baseline medications,they experience multiple episodes of acute pain daily, necessitating immediate relief.BTcP episodes are unpredictable and can occur with or without external triggers,such as movement or coughing. Many BTcP patients are already taking opioids for chronicpain management, and they often develop tolerance to these medications over time.This means they may require higher doses or more potent opioids to controlbreakthrough pain episodes.

BTcP is most common in patients with advanced-stagecancer but can occur in earlier stages, particularly during intensive treatments likechemotherapy or radiation.The Dominance of Fentanyl-Based TreatmentsFentanyl-based drugs are the leading treatments for BTcP due to their rapid onsetand high potency. Fentanyl is a synthetic opioid that is 50 to 100 times more potentthan morphine, making it ideal for managing short, intense episodes of pain. TheFDA has approved several formulations of fentanyl specifically for BTcP, includingbuccal tablets, lozenges, sublingual sprays, and nasal sprays, all designed to deliverfast pain relief.However, reliance on fentanyl-based treatments presents significant risks.

Below is asummary of the FDA-approved drugs for BTcP, including their status regarding RiskEvaluation and Mitigation Strategies (REMS), which are required for most opioid-based therapies due to concerns over abuse, addiction, and overdose.



As you can see the regulatory envionment for the current treatments is really getting difficult or closing.

I find all this very interesting in the context of our proposed THC/inhalation based drug device combination.

keen to hear others throughts...