Vivozon’s Non-opioid pain killer granted FDA’s fast track designation

Korea based Vivozon Inc announced their Fast Track Designation for VVZ-149




MMS Holdings announced their successful assistance of Korea based Vivozon Inc to achieve a Fast Track Designation from the Food and Drug Administration (FDA) for VVZ-149, a non-opioid pain killer.

VVZ-149 is a new mechanism-based non-narcotic and non-NSAID analgesic demonstrating robust pain-suppressing efficacy in a panel of in vivo models (post-operative, formalin-induced or neuropathic pain model). This is in additional to a substantial opioid sparing effect with excellent safety profiles in clinical trials to date.

"Given the global opioid crisis, meaningful alternatives are needed for patients who require effective pain relief"

VVZ-149 has also shown an anti-itching effect in the serotonin-induced itching model. These in vivo efficacies are attributed to the synergistic dual antagonistic activity of VVZ-149 against GlyT2 and 5HT2A, key receptors for the transmission of pain signals in the spinal dorsal horn area and/or peripheral sensory neurons.

Uma Sharma, PhD, Chief Scientific Officer at MMS said “given the global opioid crisis, meaningful alternatives are needed for patients who require effective pain relief”.

RELATED: David B Sudzus takes a look at what's next in the fight against the opioid crisis

 

Growth of the global opioid crisis

The management of acute and chronic pain has often included opioid therapy. This form of treatments comes with a number of side effects, such as risk of nausea, vomiting, respiratory depression and physical dependence. Opioids also carry the risk of abuse and addiction, which has been seen to be the trend globally.

According to the National Institute on Drug Abuse, in the United States alone, more than 115 people die from overdosing on opioids every day.  Canada reported 2,816 opioid related deaths in 2016. While the UK, responsible for one in three of all of Europe’s overdose deaths, saw opioid prescriptions increase by 12 million in just ten years.

In the United States alone, more than 115 people die from overdosing on opioids every day

Many have speculated as to the root cause of the crisis. Some have focused on the early stage manipulation which led many to believe that opioids were not as potently addictive as they have shown to be. Others point to the culture of overprescribing opioids, which in the 1980s meant that propozyphene was the second most dispensed drug in the US. However, the National Academy of Science has pointed out that the crisis is also a result of a number of structural factors such as lack of economic opportunity, poor working conditions and eroded social capital in depressed communities.

With opioid overdoses on the rise, increasing by 30% in the US in just one year, and an estimated 29% of patients likely to misuse prescribed opioids, President Donald Trump declared the crisis to be a public health emergency.

With an estimated 29% of patients likely to misuse prescribed opioids, the US’s Department of Health is providing support to speed up scientific solutions for the opioid crisis

One of the key focus points for the US’s Department of Health and Human Services is providing support for cutting edge research on pain and addiction, while advancing better practices for pain management. In April 2018, at the National Rx Drug Abuse and Heroin Summit, NIH Director Francis S Collings M.D, Ph.D. announced  the launch of the HEAL (Helping to End Addiction Long-Term) Initiative. This is an aggressive, trans-agency effort to speed scientific solutions focused on the opioid public health crisis.

 

Medical device, diagnostics and app based treatments

After President Trump ordered all agencies to take action on the abuse of opioids, a new initiative was launched by the FDA to use medical device based treatments, diagnostic tests and mobile medical apps to address the crisis.

The FDA told Reuters that since launching the initiative it had received over 200 submissions from companies seeking a speedy approval process for their device. Speaking about the submissions, Scott Gottlieb, the FDA Commissioner, said “we’re pleased by the robust interest in this innovation challenge and the acknowledgement from developers about the unique and important role medical devices, including digital health technologies like mobile medical apps, have the potential to play in tackling the opioid crisis”.

Since the FDA initiative to support medical device based pain treatments was launched, there have been over 200 submissions

The regulatory push for alternatives to opioids has also led to interest from venture capital funds and institutional investors. Virpax Pharmaceuticals, a privately held company producing a non opioid drug in an aerosol spray, said it had five banks interested in running its Series A investment round in summer, as opposed to one in the past year.

Read More: Andrew Love discusses the crucial changes from new medical device regulations

 

Dual-approach to pain management

The FDA has been increasingly reluctant to greenlight new opioids for market. However, earlier this year it did approve a potent opioid based painkiller from AcelRx, but there were tight restrictions placed on its distribution and use. In contrast, there are 120 non-opioid drugs under FDA review, an increase of 650 per cent since 2013.

While opioids will certainly continue to have a place in pain management, the use of non-opioid medication options may limit the amount of opioid necessary or even result in improve pain control.

There are 120 non-opioid drugs under FDA review, an increase of 650 per cent since 2013

Considering that the majority of both acute and chronic pain is thought to be complex and multifactorial, a multimodal analgesic approach is ideal for management. For example, the IV Acetaminophen (Ofirmev) is indicated for use in management of mild to moderate pain and moderate to severe pain with adjunctive opioid analgesics. IV acetaminophen has been shown to decrease opioid consumption following major surgery by nearly one-third compared with a placebo.

We can expect to see continued developed in this field, with new treatments, different forms of treatments and adaptive techniques being quickly developed to address this ongoing crisis.

 

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