The first vaping addiction treatment, developed by Achieve Life Sciences, has been designated a “breakthrough therapy” by regulators, the company reported. This status means the company can get the product to market faster and skip the last phase of clinical trials. Achieve’s stock gained on the news.
Details
The U.S. FDA granted the “breakthrough therapy” designation to Achieve’s cytisinicline-based treatment for nicotine addiction from vaping and smoking e-cigarettes. The decision was based on phase II of clinical trials (there are three phases in total — Kursiv). According to the company, the cytisinicline therapy more than doubled the odds of giving up e-cigarettes compared with placebo.
The FDA first introduced the breakthrough therapy designation in 2012. This process may be granted to drugs for treating serious illnesses if they demonstrate a substantial improvement over available ones. The effectiveness of modern drugs can already be observed in phase II of clinical trials, so major research is not required in phase III. Moreover, such a delay could even be considered unethical, as patients have to wait longer for much-needed treatment, the Russian publication GxP News summarized the arguments in favor of the “breakthrough therapy” designation. More than 130 products have been granted the designation since 2012.
Achieve Life Sciences stock added 1% on Wednesday, July 31, to $4.98 per share. After the close, it gained another 3.82% to $5.17 per share. Achieve has lost 11% over the last 12 months but is up almost 21% since the beginning of the year.
About the company
The company is developing the first treatment in the U.S. for vaping addiction based on cytisinicline and plant-derived alkaloids. In the first quarter, the company wrapped up phase II of clinical trials with 160 smokers participating and phase III with 810.
The treatment “exceeded expectations on safety and efficacy parameters,” Zacks Small Cap Research wrote following phase III.
Zacks SCR sees Achieve stock as undervalued and thinks it should trade at at least $30 per share. Meanwhile, the average target price across six analysts is $18 per share, indicating upside of more than 250% versus the closing price on Wednesday.
