FDA Moves to Restrict Flavored E-Cig Sales, Ban Menthol Cigarettes

THURSDAY, Nov. 15, 2018 — The U.S. Food and Drug Administration said Thursday it will take steps to limit or ban access to flavored e-cigarettes, menthol cigarettes and flavored cigars.

The move against flavored e-cigarettes stops short of the full ban that had been expected from the agency. Instead, sales of these products — thought to be especially alluring to teens — will only be allowed in stores within special closed-off areas made inaccessible to minors, The New York Times reported.

More unexpected was the FDA’s proposed ban on menthol cigarettes and flavored cigars, products which have long been thought to disproportionately harm the health of black Americans.

The menthol ban still has regulatory hurdles to overcome, so removal of those products from the market could take two years, the Times noted.

Still, the move would come as a huge blow to the tobacco industry, since menthols make up more than a third of the cigarette market.

All three moves are aimed at curbing uptake of vaped and smoked nicotine by the young. More than 3.6 million Americans under the age of 18 now vape, the agency noted.

The announcements come after the leading vape maker, Juul Labs, announced Tuesday that it would voluntarily withdraw most flavors of its hugely popular vaping product from the marketplace.

Juul, which controls 70 percent of the e-cigarette market, has come under increasing pressure to do something about the surging popularity of its vaping devices among youth.

In a statement released Tuesday, Juul CEO Kevin Burns said, “Our intent was never to have youth use Juul. But intent is not enough. The numbers are what matter, and the numbers tell us underage use of e-cigarettes is a problem.”

And in a statement released Thursday, FDA Commissioner Dr. Scott Gottlieb noted that “almost all adult smokers started smoking when they were kids. Today, we significantly advance our efforts to combat youth access and appeal with proposals that firmly and directly address the core of the epidemic: flavors.”

Nevertheless, the decision to restrict but not ban flavored e-cigarettes came as a surprise, since leaked documents had suggested a full FDA ban was imminent. In the end, the complex legalities of imposing a ban may have meant drawn-out court battles, something the FDA may have wanted to avoid, legal experts told the Times.

Instead, Gottlieb said that within the next three months, e-cigarette manufacturers should remove the products from “where kids can access them and from online sites that do not have sufficiently robust age-verification procedures.”

Anti-smoking advocates expressed some disappointment at the FDA’s announcement, however.

“We commend the FDA for recognizing the grave threat posed by electronic cigarettes on our children, and for imposing restrictions on manufacturers,” Nancy Brown, CEO of the American Heart Association, said in a statement.

“With e-cigarette use having jumped by 78 percent among high school students and 48 percent among middle school students, the need for action is urgent,” she added. “But limiting the sale of e-cigarettes is not enough — the FDA should also remove flavored e-cigarettes from the market and prohibit companies from marketing their products in ways that appeal to kids.”

And Matt Myers, president of Campaign for Tobacco-Free Kids, wondered to the Times, “Does this mean a simple curtain with a sign like we used to see at the entrance to the pornography section of video stores?”

Lyle Beckwith, a spokesman for the National Association of Convenience Stores, said his group “will be reviewing the regulation and advising our members accordingly” as to how to best implement the new rules.

He noted that, according to his teenaged son, most minors already get their flavor pods from older youth, not convenience stores.

The FDA first began its crackdown on flavored e-cigarettes earlier this year, as the number of teens using the products reached epidemic proportions, the Times reported. By far, the leading vaping product is made by Juul, whose e-cigarette devices resemble small computer flash drives. Use of Juul has skyrocketed among teens over the past year.

Flavored versions of e-cigarettes — including chicken and waffles, rocket Popsicle and “unicorn milk” — have boosted sales among the young even further, experts contend.

“The availability of flavors in e-cigarettes is one of the top reasons that middle and high school students cite as their motivation for using e-cigarettes,” said Patricia Folan, director of the Center for Tobacco Control at Northwell Health in Great Neck, N.Y. “Young people are more likely to try flavored e-cigarettes and consider them less harmful than tobacco-flavored e-cigarettes.”

The vaping industry has countered that flavored e-cigarettes actually provide a potential health benefit, helping to encourage tobacco smokers to quit.

“Flavors are important for switching,” Dr. Moira Gilchrist, a scientist with Philip Morris International, said during a visit to Washington in October for an FDA public meeting. Phillip Morris hopes to market its IQOS heat-not-burn device in the United States in tobacco and menthol flavors.

“The focus should be on what is the right thing to do for the 40 million men and women in the United States who would otherwise continue to smoke cigarettes,” she said.

As for the ban on menthol cigarettes and flavored cigars — both highly favored by black Americans — challenges lie ahead. The U.S. tobacco industry has long fought hard against such a ban. But health advocates were heartened by the news.

“Studies show that menthol cigarettes increase initiation, especially among youth,” Brown noted. “Menthol also has a disproportionate impact on minorities including African-Americans, who favor menthol cigarettes and find them more difficult to successfully quit.”

Delmonte Jefferson, executive director of the National African American Tobacco Prevention Network, told the Times, “While we’re saddened by the number of lives lost and new smokers addicted over the past decade, we’re pleased that the FDA is moving in this direction.”

The group also praised the agency for taking on flavored cigars.

“Little cigars like Black & Milds and Swisher Sweets are heavily marketed to African Americans and are often cheaper in our neighborhoods,” said LaTroya Hester, a spokesman for the network. “A lot of young, black kids don’t know that cigarillos are just as dangerous, so hopefully this will send that message. This is a huge step in protecting their health. It’s about time our young people are prioritized.”

More information

The U.S. National Institute on Drug Abuse has more about e-cigarettes.

Posted: November 2018

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FDA Considers Curbing E-Cigarette Sales After Stats Show A Surge In Teen Vaping

Following a huge increase in vape users among teenagers, the Food and Drug Administration (FDA) plans to impose restrictions in the sale of e-cigarettes throughout the United States.

According to a news report by the Washington Post, the action will potentially affect the industry that has grown “exponentially” over the years with little oversight by the government.

The report quoted a senior agency official and detailed that the Commissioner of FDA, Scott Gottlieb, is expected to ban the sale of most flavored e-cigarettes which are freely available in tens of thousands of gas stations and convenience stores across the country.

Apart from flavored e-cigarettes, there are plans to ban menthol in regular cigarettes as well. According to the report, the decision hasn’t been taken suddenly, and the agency has been collecting comments from the public on such a prohibition. The move will likely receive severe backlash from the cigarette industry.

The expected decision to impose a ban on the sales of e-cigarettes was spurred after preliminary statistics by the government revealed that in 2018, the use of e-cigarettes has increased to 7.7 percent among high schoolers and close to 50 percent among middle schoolers, the report by the Washington Post said. The current statistics show that 3.5 million children across the country were vaping at the beginning of 2018, and above 1 million from 2017

According to the report, Gottlieb was previously a member of the board of a North Carolina vaping company and once favored the e-cigarette industry, had delayed some critical e-cigarette rules after assuming the office of commissioner in 2017.

Recently, however, he has said that his “first priority is protecting children from tobacco-related disease.” Shedding light on the vaping data, Gottlieb said during an interview before his final decision on e-cigarette policy that strict action will be taken to save the younger generation from nicotine addiction.

“We now have evidence that a new generation is being addicted to nicotine, and we can’t tolerate that.”

The federal government also said on Thursday, November 8, that cigarette smoking has reached the lowest level ever recorded among U.S. adults, and that the rate of smoking among young people has dropped even farther, per USA Today.

The data — provided by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration and the National Cancer Institute (NCI) — showed that about 14 percent of adults in the U.S. — or 34 million people –regularly smoked cigarettes or some days in the previous month, down from 15.5 percent in 2016. The stats further showed that “about 10 percent of people aged 18 to 24 years smoked cigarettes in 2017, down from 13 percent in 2016.”

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FDA Takes on Flatulent Cows

TUESDAY, Nov. 6, 2018 — The first drug to combat farting in livestock has been approved by the U.S. Food and Drug Administration.

Yes, you read that right: When fed to beef cattle under specific conditions, Experior results in less ammonia gas released by the animals and their waste.

“Today we’re announcing the approval of the first animal drug that reduces ammonia gas emissions from an animal or its waste. These ammonia gasses can come from many sources and can affect the health of people, animals and the environment,” Steven Solomon, director of the FDA’s Center for Veterinary Medicine, said in an agency news release.

Ammonia gas emissions can cause atmospheric haze and noxious odors, and high concentrations of ammonia can cause irritation of the eyes, nose and throat in both humans and animals, according to the FDA.

Also, ammonia gases can contribute to bodies of water being loaded with excess nutrients, especially nitrogen and phosphorous. This can cause algae blooms that block sunlight to aquatic plants, eventually resulting in the death of fish and other creatures due to a lack of oxygen in the water.

Studies showed that the drug partially reduces ammonia gas emissions from manure produced by a single animal or a pen of animals, but did not assess its effectiveness on a larger scale.

Other studies showed that Experior is safe to feed to beef cattle and that meat from cattle treated with the drug is safe for people to eat, according to the FDA.

More information

Texas A&M has more on cattle and ammonia emissions.

Posted: November 2018

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FDA Approves Sympazan

WARREN, N.J., Nov. 2, 2018 /PRNewswire/ — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Sympazan™ (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.1 Sympazan is the first and only oral film FDA-approved to treat seizures associated with LGS. Previously, clobazam was marketed as ONFI® and offered in two formulations – either tablet or oral suspension.2

"Aquestive Therapeutics is pleased to bring Sympazan to the LGS community," said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. "Treating LGS can be difficult; patients may have a hard time swallowing oral medications. We're optimistic Sympazan can help address unmet medical needs and be an important treatment option for this patient population."

LGS is a severe form of epilepsy that begins in early childhood and is characterized by multiple types of seizures and intellectual disability.3 LGS patients often have difficulty swallowing pills and large volume suspensions due to physical limitations, behavioral or cognitive impact.4,5 Challenges with treatment administration can lead to uncertain and inconsistent dosing, and increase the burden of care, particularly for patients that may be combative or resistant to treatment.5-8

Since FDA approval in 2011, clobazam tablets and oral suspension (brand name ONFI®) have been a trusted adjunctive treatment for LGS. In a Phase 3, randomized, double-blind, placebo-controlled study of 238 LGS patients, clobazam tablets significantly reduced the frequency of drop seizures (which involve falls) compared to baseline by 41 percent (low dose) to 68 percent (high dose) vs. 12 percent for placebo (p<0.05 for all doses vs. placebo).2,9 Please see more Important Safety Information below, including the Boxed Warning on the risks associated with concomitant use of opioids.

"Many LGS patients have a hard time swallowing pills and suspensions. This can make administering medication hard for caregivers," says Christina SanInocencio, Executive Director of the LGS Foundation. "We believe Sympazan will be welcomed by patients and caregivers impacted by LGS and searching for treatment solutions."

Sympazan is a formulation based on Aquestive's proven PharmFilm® technology. Multiple pharmacokinetic studies were conducted to compare Sympazan with ONFI. Based on the studies, Sympazan oral film was demonstrated to be bioequivalent to clobazam tablets and have comparable safety profiles.1 Aquestive's clinical development of Sympazan followed the 505(b)(2) regulatory pathway.

"Sympazan is the beginning of a meaningful CNS franchise for Aquestive," Kendall says. "We are actively working to advance more redesigned, proprietary treatments that can offer meaningful improvements for patients and caregivers who live with epilepsy and other complex conditions."

Aquestive plans to commercialize Sympazan in November, and has engaged Ashfield Healthcare, a company specializing in commercialization services, to build and train a highly qualified, national sales force. The sales force will focus on pediatric neurologists and epileptologists.

Sympazan oral film is berry flavored and offered in 5 mg, 10 mg, and 20 mg dosages to meet a range of LGS patient and caregiver needs.1

About Aquestive Therapeutics

Aquestive Therapeutics is a specialty pharmaceutical company committed to identifying, developing and commercializing differentiated products to address unmet medical needs. Aquestive Therapeutics has a late-stage proprietary product pipeline focused on the treatment of CNS diseases, and is working to advance orally-administered complex molecules that it believes can be alternatives to invasively-administered standard of care therapies. As the leader in developing and delivering drugs via its PharmFilm® technology, Aquestive Therapeutics also collaborates with pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

CONTRAINDICATIONS

Sympazan is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions.

WARNINGS AND PRECAUTIONS

Potentiation of Sedation from Concomitant Use with Central Nervous System (CNS) Depressants
Sympazan has a CNS depressant effect. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol as the effects of other CNS depressants or alcohol may be potentiated.

Somnolence or Sedation
Sympazan causes dose-related somnolence and sedation, which generally begins within the first month of treatment and may diminish with continued treatment. Monitor patients for somnolence and sedation, particularly with concomitant use of other CNS depressants. Caution patients against engaging in hazardous activities requiring mental alertness, i.e., operating dangerous machinery or motor vehicles, until the effect of Sympazan is known.

Withdrawal Symptoms
Abrupt discontinuation of Sympazan should be avoided. The risk of withdrawal symptoms is greater with higher doses. Withdraw Sympazan gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus.

Serious Dermatological Reactions
Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults. Discontinue Sympazan at the first sign of rash, unless the rash is clearly not drug-related.

Physical and Psychological Dependence
Patients with a history of substance abuse should be under careful surveillance when receiving Sympazan.

Suicidal Behavior and Ideation
AEDs, including Sympazan, increase the risk of suicidal thoughts or behavior in patients. Patients treated with Sympazan should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Inform patients, their caregivers, and families of the increased risk of suicidal thoughts and behaviors. Advise them to be alert for and report immediately to healthcare providers any emergence or worsening signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm.

ADVERSE REACTIONS

Adverse reactions (≥10% and more frequently than placebo) included constipation, somnolence or sedation, pyrexia, lethargy, and drooling.

DRUG INTERACTIONS

The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. Limit dosage and duration of concomitant use of benzodiazepines and opioids and follow patients closely for respiratory depression and sedation. Concomitant use of Sympazan with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol, as effects of other CNS depressants or alcohol may be potentiated. Hormonal contraceptives that are metabolized by CYP3A4; effectiveness may be diminished when given with Sympazan. Additional non-hormonal forms of contraception are recommended when using Sympazan. Dose adjustment may be necessary of drugs metabolized by CYP2D6 and of Sympazan when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine).

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation: Sympazan may cause fetal harm and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have taken benzodiazepines during the later stages of pregnancy can develop dependence, withdrawal syndrome and symptoms suggestive of floppy infant syndrome. Sympazan is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Sympazan, discontinue nursing or discontinue the drug. Encourage patients to call the toll-free number 1-888-233-2334 to enroll in the Pregnancy Registry or visit http://www.aedpregnancyregistry.org/.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "project," "will," "would," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. Such statements include, but are not limited to, statements about regulatory approvals and pathways, clinical trial timing and plans, the achievement of clinical and commercial milestones, future financial and operating results, business strategies, market opportunities, financing, and other statements that are not historical facts.

These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials; the risks of delays in FDA approval of our drug candidates or failure to receive approval; the risks inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); development of our sales and marketing capabilities; the rate and degree of market acceptance of our product candidates; the success of any competing products; the size and growth of our product markets; the effectiveness and safety of our product candidates; risks associated with intellectual property rights and infringement; unexpected patent developments; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Registration Statement on Form S-1 declared effective by the SEC on July 24, 2018. As with any pharmaceutical product candidate under development, there are significant risks with respect to the development, regulatory approval and commercialization of new products. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. We assume no obligation to update our forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required under applicable law.

References:

SOURCE Aquestive Therapeutics, Inc.

Posted: November 2018

Sympazan (clobazam) FDA Approval History

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