Valeritas Holdings VLRX Stock News

Valeritas Holdings Inc (NASDAQ: VLRX) is making a run for the top this morning, trading on early gains of well over 16%. The gains come after the company announced the successful delivery of CBD through a wearable delivery device in a preclinical study. Here’s what’s going on:

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VLRX Stock Climbs On Successful Subcutaneous Delivery Of CBD

In a press release issued early this morning, Valeritas Holdings provided results from a preclinical pharmacokinetic study of CBD subcutaneous infusion with two dosing regimens. The delivery of CBD was enabled using the company’s proprietary h-Patch wearable drug delivery device.

This is big news as it is the first ever study that resulted in CBD being delivered via subcutaneous infusion.

The h-Patch is a product that was designed by VLRX for the purpose of facilitating the simple and effective subcutaneous delivery of injectable medicines to patients. This technology is used in the company’s V-Go insulin delivery device product. V-Go is the first ever FDA-approved product that uses h-Patch technology. More than 20 million V-Go devices have been sold to date.

In the preclinical study, the company evaluated CBD delivered over a 24-hour period through the use of the h-Patch. PK was evaluated at time points through a 48 hour period from the start of infusion.

In the release, VLRX said that both doses showed rapid absorption and distribution. Moreover, CBD levels in the blood changed within one hour and was still detectable 24 hours after completion of the infusion.

An Important Step Forward

This preclinical study is an important step forward in the discussion of CBD. While it is believed that the derivative of the hemp and cannabis plants could result in liver toxicity over long-term use due to exposure to toxic metabolites. Moreover, orally administered CBD has very low bio-availability.

The h-Patch addresses these concerns by providing a continuous basal delivery rate and maximizing therapeutic effect by avoiding the first-pass effect and eliminating peak/trough variations of drug exposure.

This method of CBD delivery could come with several rewards. In particular, delivery directly to the bloodstream will greatly minimize the amount of the drug that is metabolized by the liver, leading to exposure and therefore, lower toxicity. It is also believed that due to the bioavailability of CBD through this method, the overall amount of CBD needed for desired results is drastically reduced.

In a statement, John Timberlake, President and CEO at VLRX, had the following to offer:

This study highlights Valeritas’ partnering opportunities to leverage the h-Patch™ technology beyond insulin delivery. Subcutaneous infusion is a powerful delivery method for a variety of drugs with solubility, permeability, and first-pass metabolism challenges, and the h-Patch™ may offer a cost-effective alternative means of reliable and patient-friendly drug dosing.

This News Is Big

The successful delivery of CBD using the h-Patch is huge news for Valeritas Holdings and its investors. First and foremost, the CBD market is expected to grow to be worth $20 billion by the year 2024. That is a massive number for an emerging market.

Should the h-Patch technology continue to show such strong results, the product that results could become a cornerstone in how we view, and use, CBD. While many are likely to continue with vapes and other forms of oral delivery, some health-concious over the counter CBD users would likely want an option like this.

Moreover, from a medical perspective, this could be a game changer. Parents of epileptic children who are prescribed Epidiolex (the first cannabis-derived treatment approved by the FDA, provided by GW Pharmaceuticals (NASDAQ: GWPH) who are concerned about liver toxicity, may look to other options.

Moreover, considering that VLRX may have a delivery method that leads to a low chance of side effects, we may see GWPH approach the company to license the technology or even consider an acquisition. All in all, this is big news whether you look at it from an over the counter implications or the potential of a deal from a large pharma company.

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