The J.P. Morgan Chase healthcare conference certainly has something to do with it, and developments out of the conference are currently dominating biotech news. As noted already, some of the developments in the sector have had a profound impact on related companies, Axsome and Pain Therapeutics included.
On Tuesday, Axsome reported that an independent data monitoring committee (IDMC) has recommended the discontinuation of one of its lead development programs. The program is investigating a drug called AXS-02 in a target indication of complex regional pain syndrome (CRPS). At the time of the recommendation, the program was in a Phase III trial.
CRPS is a long-term pain syndrome that comes about on the back of an often minor injury that worsens with time. It’s characterized by severe pain out of proportion to the original injury and is normally accompanied by sensitivity, swelling, and changes in the skin.
The drug is an inhibitor of bone‑reabsorbing cells called osteoclasts. When osteoclasts break down, they secrete acid, which stimulates pain receptors. The idea behind the drug was that by inhibiting the breakdown of osteoclasts, stimulation of pain receptors can ben minimized.
It is a neat mechanism of action but it doesn’t seem to be particularly effective in CRPS unfortunately. The discontinuation recommendation is rooted in futility, suggesting that the IDMC doesn’t feel that the drug can meet its predefined efficacy endpoints if it is allowed to continue to trial completion.
The company is trading down a little over 36% on the back the news but it’s not all bad. The same IDMC recommended that the company’s other Phase III trial, COAST-1 for AXS-02 in knee osteoarthritis (OA) associated with bone marrow lesions (BMLs) should continue to full enrollment.
The continuation recommendation doesn’t necessarily mean that the drug is going to perform successfully against its endpoints in the OA indication but it does provide a degree of favorability over the CRPS indication.
Also a data-driven move here but, fortunately for Pain Therapeutics’ shareholders, it’s in the opposite direction.
The company just put out data from a human abuse potential study of REMOXY.
As measured in non-dependent, recreational opioid users, nasal administration of the company’s drug resulted in significantly lower abuse potential compared to immediate-release oxycodone.
All study subjects reported reduced ‘Drug Liking’ ‘Take Drug Again’ and ‘Drug High’ as compared to IR oxycodone. REMOXY showed lower exposure to oxycodone, lower peak concentrations (Cmax) and longer time to peak drug concentration (Tmax) against comparator drugs.
All of these results taken together suggest a strong trend towards abuse deterrence, a major boon for Pain Therapeutics and shareholders.
The FDA has issued two complete response letters related to this asset in the past, one in 2011 one in 2016, requesting further confirmation of abuse-deterrent properties. It looks as though REMOXY could finally pick up a regulatory approval in its target indication and the company is obviously trading up on the news.
The company expects to resubmit a New Drug Application (NDA) for REMOXY at some point during the first quarter of 2018, meaning we could see an approval before the end of this year.
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