Smoking Cessation

Feb. 29, 2024 -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the adequacy and timing of long-term cytisinicline exposure data requirements for a New Drug Application (NDA). During pre-NDA discussions held in the fourth quarter of 2023, the FDA expressed support for an NDA submission based on adequate data to assess for efficacy from the two completed randomized and controlled Phase 3 trials, ORCA-2 and ORCA-3. In addition, the FDA advised that long-term exposure data to assess for safety beyond 12 weeks would be needed to adequately evaluate safety risks given that the FDA views smoking cessation drugs as products for chronic, repeat, or intermittent use as patients may relapse and require subsequent courses of treatment over a lifetime. Achieve and the FDA have reached agreement that a single, open-label study evaluating for long-term safety exposure of cytisinicline will be sufficient to complete the requirement and enable an NDA submission anticipated in the first half of 2025. Based on FDA agreement, Achieve's NDA submission will include safety data on at least 300 subjects who have received cumulative cytisinicline treatment for six months. Prior to potential approval, Achieve will provide the FDA with safety data from at least 100 subjects treated with cytisinicline for a cumulative duration of one year. Achieve plans to initiate the “ORCA-OL” open label exposure trial in the second quarter of 2024, which will include investigators and sites who have participated in the ORCA clinical trial program (ORCA-2, ORCA-3, and ORCA-V1 studies). ORCA-OL will recruit from the more than 1,700 subjects who have participated in these prior trials, including more than 1,100 who have already received cytisinicline treatment for either 6 or 12-weeks. The required total cumulative exposure data for NDA submission and potential final approval will combine the previous subjects’ treatment received during their respective ORCA-2, ORCA-3, or ORCA-V1 study participation plus their exposure during the ORCA-OL study. This allows for faster collection of cumulative long-term exposure safety data for the NDA submission. Subjects in ORCA-OL will receive cytisinicline treatment for up to one year and will be monitored for safety. “We anticipate that data from this long-term exposure study will support the expected use of cytisinicline by patients multiple times throughout their journey to nicotine abstinence,” commented Cindy Jacobs, Achieve’s President & Chief Medical Officer. “Additionally, we expect this safety data will be supportive of a future cytisinicline label expansion for vaping cessation.” Achieve also announced an approximately $124.2 million financing, which includes $60 million upfront from the sale of common stock and up to an additional $64.2 million upon the exercise of milestone-driven warrants. The milestone-driven warrants will expire on the earlier of (i) three and one-half years following the date of issuance and (ii) 30 days following Achieve’s public disclosure of the acceptance of an NDA for cytisinicline by the FDA in a Day 74 Letter or equivalent correspondence. Achieve has also reached non-binding agreement with Silicon Valley Bank on an extension of the maturity date into December 2025 on its outstanding loan. “We are pleased to now have clarity from the FDA and we are excited about the vote of confidence from leading life science investors who share our enthusiasm for cytisinicline’s potential,” said John Bencich, Achieve’s Chief Executive Officer. “As we continue our discussions with potential commercial partners, we are funded to conduct the ORCA-OL trial and complete the planned NDA submission, bringing us closer to our goal of helping the millions of people who struggle with nicotine dependence.” Achieve expects that existing cash, cash equivalents and restricted cash, together with the net proceeds from the financing, will provide adequate funding through the anticipated NDA filing in the first half of 2025. If all of the milestone-driven warrants are exercised in full, Achieve expects to have runway into 2026 and through potential FDA approval. Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are an estimated 28 million adults in the United States alone who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.3 In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.3  In 2023, approximately 2.1 million middle and high school students in the United States reported using e-cigarettes.4 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com. References 1Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483. 2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 4Birdsey J, Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle and High School Students — National Youth Tobacco Survey, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1173–1182. The content above comes from the network. if any infringement, please contact us to modify.

SEATTLE, Wash and VANCOUVER, British Columbia, Sept. 27, 2022 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that target enrollment of 750 subjects has been reached in the Phase 3 ORCA-3 trial. Similar to the previously reported ORCA-2 trial, ORCA-3 is evaluating the smoking cessation efficacy, safety, and tolerability of 3 mg cytisinicline dosed three times daily (TID) for either 6 or 12 weeks compared with placebo. ORCA-3 participants will be monitored through 24 weeks post randomization and will receive standard behavioral support for the duration of the trial. More than 750 adult smokers have been randomized across 20 clinical trial locations in the United States. Trial sites are no longer enrolling new subjects, but those currently in screening will be allowed to participate provided they meet entry criteria. Topline results are expected to be reported in the first half of 2023. “We are pleased to have completed enrollment in this second confirmatory Phase 3 trial that we expect will fulfill the clinical requirements for regulatory submission in the U.S., and ultimately, if approved, enable cytisinicline availability to the millions of American smokers who desperately need new treatment options to help them overcome their nicotine addiction,” stated John Bencich, Chief Executive Officer of Achieve. “We would like to extend our gratitude to the ORCA-3 clinical research teams, and importantly, the smokers who endeavored a quit attempt through participation in this study. We wish them continued success on their quit journey.” In April 2022, Achieve announced positive, statistically significant results in its Phase 3 ORCA-2 clinical trial of cytisinicline in 810 adult smokers across 17 clinical trial locations in the United States. ORCA-2 evaluated the efficacy and safety of 3 mg of cytisinicline dosed three times daily for either 6 or 12 weeks compared to placebo in adult smokers. Both the primary and secondary endpoints demonstrated increased quit rates, showing 6-8 times increased odds of smoking abstinence when compared to placebo. Cytisinicline was well tolerated with single-digit rates of adverse events observed and no treatment-related serious adverse events reported. If approved by the U.S Food and Drug Administration, or FDA, cytisinicline would be the first, non-nicotine smoking cessation prescription treatment made available to American smokers in nearly two decades. For more information on cytisinicline or the ORCA-3 trial, please visit www.achievelifesciences.com. About ORCA-3 The ORCA-3 trial is Achieve Life Sciences’ second randomized Phase 3 trial evaluating the efficacy and safety of cytisinicline as a treatment for smoking cessation in adult smokers at 20 clinical trial locations in the United States. Smokers were randomized to one-of-three treatment arms to receive either placebo or 3 mg cytisinicline taken three times daily (TID) for a period of either 6 or 12 weeks. Similar to the ORCA-2 trial, which was the first randomized Phase 3 clinical trial to show a smoking cessation benefit in nearly two decades, the primary outcome measure of success in ORCA-3 is biochemically verified continuous abstinence during the last four weeks of treatment in the 6- and 12-week cytisinicline treatment arms compared with placebo. Each treatment arm in the trial will be compared independently to the placebo arm. The trial will be deemed successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. Secondary outcome measures will be conducted to assess continued abstinence rates through six months from the start of study treatment. ORCA-3 topline results are expected in the first half of 2023. About Achieve and Cytisinicline Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2 In addition, there are nearly 11 million adults in the United States who use e-cigarettes, also known as vaping.3 While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease.4 In 2021, e-cigarettes were the most commonly used tobacco product reported by 1.72 million high school students.5 Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never vaped.6 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com.

Increase in prevalence of cataract surgery, surge in adoption of advanced premium intraocular lens, and development of new intraocular lens by the large number of key players drive the growth of the global intraocular lens market. PORTLAND, Ore. , June 7, 2022 /PRNewswire/ -- Allied Market Research published a report, titled, "Intraocular Lens Market by Type (Monofocal Intraocular Lens, Premium Intraocular Lens), by Material (Polymethylmethacrylate, Silicone, Hydrophobic and Hydrophilic Acrylic Materials), by End User (Hospitals, Ambulatory Surgery Centers, Ophthalmology Clinics, and Eye Research Institutes): Global Opportunity Analysis and Industry Forecast, 2021-2031." According to the report, the global intraocular lens market size generated $3.8 billion in 2021, and is expected to reach $6.5 billion by 2031, witnessing a CAGR of 5.6% from 2022 to 2031. Download Sample PDF at: Drivers, Restraints, and Opportunities Increase in prevalence of cataract surgery, surge in adoption of advanced premium intraocular lens, and development of new intraocular lens by the large number of key players drive the growth of the global intraocular lens market. However, unsupportive reimbursement scenario for premium lens and postoperative issues such as refractive errors restrain the market growth. On the other hand, technological innovations and rise in number of product approvals create new opportunities in the coming years. Covid-19 Scenario During the Covid-19 pandemic, patients suffering from cataract and other eye-related issues were hesitant to seek immediate care due to possibility of cross-contamination in hospitals and clinics. Many ophthalmologists had to close their practices temporarily. The visits to eye clinics or hospitals lowered down significantly. According to the study conducted by National Center of Biotechnology Information in 2021, the patient visits to eye care hospitals reduced by 3.5% during the pandemic. This, in turn, reduced the demand for intraocular lens and impacted the intraocular lens market negatively. The monofocal intraocular lens segment to maintain its leadership status during the forecast period Based on type, the monofocal intraocular lens segment accounted for the highest market share in 2021, contributing to more than three-fifths of the global intraocular lens market, and is expected to maintain its leadership status during the forecast period. This type of lens is the preferred choice of numerous ophthalmologists, which, in turn, led to the dominance in terms of revenue for this segment. However, the premium intraocular lens segment is expected to witness the highest CAGR of 7.2% from 2022 to 2031, owing to their proficiency in treating patients suffering from intricate retinal issues. Specific Requirement on COVID-19? Ask to Our Industry Expert: The hospitals segment to maintain its lead position during the forecast period Based on end user, the hospitals segment held the highest market share in 2021, accounting for more than half of the global intraocular lens market, and is expected to maintain its lead position during the forecast period. This is due to surge in number of cataract procedures performed in inpatient settings. However, the ophthalmology clinics segment is projected to manifest the fastest CAGR of 6.8% from 2022 to 2031. This is attributed to rise in number of discrete ophthalmic clinics. North America to maintain its dominance in terms of revenue by 2031 Based on region, North America contributed to the highest market share in terms of revenue in 2021, accounting for nearly two-fifths of the global intraocular lens market, and is expected to maintain its dominance in terms of revenue by 2031. This is due to favorable reimbursement policies for cataract treatment in this region. However, Asia-Pacific is projected to manifest the fastest CAGR of 6.9% during the forecast period. This is attributed to surge in awareness regarding advanced treatment options and huge geriatric population base susceptible to cataract. Leading Market Players Alcon Bausch Health, Inc. Carl Zeiss Meditech EyeKon Medical, Inc. Humanoptics Hoya Corporation Johnson & Johnson Lenstec, Inc. Rayner Intraocular Lens Ltd. Avenue Basic Plan | Library Access | 1 Year Subscription | Sign up for Avenue subscription to access more than 12,000+ company profiles and 2,000+ niche industry market research reports at $699 per month, per seat. For a year, the client needs to purchase minimum 2 seat plan. Request for 14 days free trial: "We have also published few syndicated market studies in the similar area that might be of your interest. Below are the report title for your reference, considering Impact of Covid-19 Over This Market which will help you to assess aftereffects of pandemic on short-term and long-term growth trends of this market." 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