Search This Blog

Monday, August 27, 2018

Teen Xanax Abuse Is Surging


Teen drug use during the summer often goes unnoticed. It’s when school starts and students nod off in class, exchange pills in the hallways and fail tests that the truth becomes apparent.
This school year, addiction specialists say they’re expecting an onslaught of teens addicted to Xanax and other sedatives in a class of anti-anxiety drugs known as benzodiazepines, or “benzos.” Many teens view Xanax as a safer and more plentiful alternative to prescription opioids and heroin — with similar euphoric effects.
But addiction experts warn that the pills kids are taking, often found in their parents’ or grandparents’ medicine cabinets, can be just as deadly as opioids, especially when taken in combination with other drugs or alcohol. And it’s much harder to kick the habit.
Like any addictive substance, Xanax when used early increases the risk of addiction later in life. According to the U.S. Surgeon General’s 2016 report on drugs and alcohol, nearly 70 percent of adolescents who try an illicit drug before age 13 will develop an addiction within seven years, compared with 27 percent for those who first try an illicit drug after age 17.
Nationwide, prescription drug abuse among adolescents has dropped dramatically in the last 15 years, according to survey results published in December by the National Institute on Drug Abuse. Last year’s results indicate that about 4 percent of high school seniors misused prescription painkillers, a sharp decline from 2004, when nearly 1 in 10 teens misused opioids.
In fact, an increasing percentage of high school kids — at least 26 percent of seniors in 2014, up from 5 percent in 1976 — are abstaining from all substances, including alcohol, marijuana and tobacco, according to an historical analysis of the survey data published in July.
Even so, addiction practitioners say they’re seeing a surge in the number of young patients who are hooked on Xanax. Many take high daily doses of the drug, sometimes in deadly combination with opioids and alcohol.
Addiction treatment centers are “the tip of the spear,” said Sharon Levy, director of adolescent addiction treatment at Boston Children’s Hospital and lead author of the adolescent drug use study. “We see things first. So, I’m not surprised that the spike in Xanax use isn’t reflected in national data yet.”
“Adolescent benzo use has skyrocketed,” Levy said, “and more kids are being admitted to hospitals for benzo withdrawal because the seizures are so dangerous.” At the same time, she said, far fewer kids are seeking treatment for prescription opioid addiction.
“When I ask them if they’re using opioids, they say, ‘No. I wouldn’t touch the stuff.’”

High Doses

Marc Fishman, an addiction psychiatrist and professor at Johns Hopkins University School of Medicine, said benzos are quickly overtaking opioids as the primary prescription drug of abuse among the adolescent patients he sees at Mountain Manor Treatment Centers in Baltimore and other Maryland locations. And many of them are extreme, high-dose users, he said.
Like opioids prescribed for pain, benzodiazepines prescribed for anxiety eventually stop working, forcing users to take higher and higher doses to get the same effect. Kids who can’t get the pills at home buy them on the dark web or concoct designer versions of benzos in their bathtubs, he said.
People with mental illness are at much higher risk for developing an addiction to opioids, and Fishman said the connection between mental illness and benzos is even stronger.
Three FDA-approved medicines are available to treat the symptoms of opioid addiction: buprenorphine (most often sold as Suboxone), methadone and Vivitrol, a long-acting injectable medicine that blocks the euphoric effects of opioids and alcohol.
But no medicines exist to blunt the withdrawal symptoms and cravings associated with benzodiazepine addiction. Instead, patients typically enter residential treatment where a specialist gradually tapers them off the medication. If stopped too quickly, benzodiazepine withdrawal can result in seizures and even death.
For people who overdose on opioids, Narcan is widely available and can easily be administered by first responders, friends and family members to block the deadly respiratory depression of opioids. A similar drug, flumazenil, can block the respiratory depression of benzodiazepines, but it is rarely available outside of hospitals.

Plentiful Supply

The burgeoning abuse of Xanax and other benzodiazepines among high school kids and young adults over the last several years primarily stems from the fact that there are more of the pills out there, Levy argued.
As more adults are prescribed Xanax, Valium, Ativan and other benzodiazepines to calm their nerves and promote sleep, “we’re creating these vast reservoirs for kids to find,” she said.
“That one idea — that something is safe or beneficial or medical — has launched many an epidemic in the past.”
Sharon Levydirector of adolescent addiction treatmentBOSTON CHILDREN’S HOSPITAL
The other problem, she said, is that adolescents think the benzos are safe because their parents use them. Many kids say they don’t take the pills to get high; they take them to feel normal, Levy said. “Some patients even ask me to just prescribe Xanax for them so they don’t have to buy it illegally. They think it’s good for them.”
“That one idea — that something is safe or beneficial or medical — has launched many an epidemic in the past,” Levy said. “So, my colleagues and I are watching this with trepidation.”

Easy to Love

Melissa Ellis, who grew up in Baltimore in what she described as an addiction-prone family, loved Xanax from the first time she tried it. “I noticed this new guy I was dating kept nodding off so I asked him what he was taking. He told me it was Xanax and gave me a handful of bars [the pill form with the highest dose]. I’d never heard of it before. But as soon as I tried it, I knew it was for me.
“It takes away everything you have in your mind that’s bothering you and everything you feel that hurts, and before you know it, those feelings are just gone.”
Melissa was 15 then and just entering high school. Now she’s 24 and struggling to take care of her 3-year-old son. She says she’s determined to beat her addiction to Xanax and be free of all drugs except the depression medicine she’s been taking for more than a decade. Otherwise, she said she could lose her son.
The first time Melissa tried to stop taking Xanax, she was four months pregnant. She managed to get through her pregnancy without relapsing. “But the day after my son was born, I told my friend in the hospital to bring me some. And I started all over again.”
Melissa also started injecting heroin then. “The two drugs are made for each other,” she said. “What one doesn’t have, the other one does. With the dope [heroin], the high doesn’t last as long as Xanax. So, I was more into the Xanax.”
But after she started combining the two, she overdosed, and her mom found her passed out on the floor one day. That’s when she first checked into Mountain Manor.
Melissa detoxed from both drugs, spent two weeks in residential treatment and started taking Suboxone to relieve her opioid cravings. She also attended outpatient classes and stayed sober for a year.
“I got so much closer to my son back then,” she said wistfully. “Everything was better. I was doing so good. But I started hanging out with old friends and I relapsed on Xanax.”
Now, she’s back at Mountain Manor, trying again. She hopes to leave treatment by the end of the week and move into a mother-and-child sober living facility nearby. For now, her mother is taking care of her son.
“It’s really hard,” Melissa says. Withdrawal from Xanax can cause irritability, insomnia, anxiety, panic attacks, tremors, nausea and other flu-like symptoms. And unlike opioid withdrawal, which usually lasts for about a week, it can last for months.
“Treatment is scary all around. It’s fine when you’re here. You can’t go down the street and meet your dealer. The scariest part is when you go back out there.”

Pfizer rare-disease drug results lift Alnylam too


Pfizer Inc. PFE, -1.73% shares rose just under 1% in Monday premarket trade after the company announced positive results from a late-stage trial of its drug tafamidis, which is being developed for the rare disease transthyretin amyloid cardiomyopathy. In the phase 3 trial, which enrolled 441 patients with the disease and took place over the course of 30 months, tafamidis was found to reduce risk of death by 30% and reduce the rate of cardiovascular-related hospitalization by 32%. By one estimate, the therapy could bring in more than $1 billion in peak sales. Transthyretin cardiomyopathy can be hereditary or caused by age, and affects the heart muscle, leading to heart failure. The Pfizer results were strong but “we see the door open to ALNY given key details of the study: 1) 20 mg not differentiated from 80 mg, and 2) more limited efficacy in the ATTRm population (vs wild-type) and would not be surprised to see ALNY shares trade up,” said EvercoreISI analyst Josh Schimmer and Steven Breazzano, who went on to say that two rival therapies, Alnylam Pharmaceuticals Inc.’s ALNY, +17.61% patisiran and Ionis Pharmaceuticals Inc. IONS, +7.67% and Akcea Therapeutics Inc.’sAKCA, +3.10% inotersen, “will generally be safe in the neuropathy population.” Alnylam shares rose 4.3% in premarket trade while Ionis and Akcea shares were inactive. The Pfizer study’s results are also being published in the peer-reviewed New England Journal of Medicine. Pfizer shares have surged 18.8% over the last three months, compared with a 3.1% decline in Alnylam shares.

Allergan, Mohawk Tribe ask rehearing in sovereign immunity patent case


Allergan plc (NYSE:AGN) and the Saint Regis Mohawk Tribe filed a petition on Aug. 20for an en banc rehearing of their patent case in front of the full U.S. Court of Appeals for the Federal Circuit (CAFC). A three-judge panel ruled in July that the tribe cannot assert sovereign immunity in an inter partes review challenging patents on Restasis cyclosporine, affirming a February decision from the Patent Trial and Appeal Board (PTAB) (see “Court Denies Appeal in Mohawk Case, Clarifies IPR’s Role”).
Allergan transferred six patents on the dry eye treatment to the tribe in September 2017in a bid to shield the patents from the IPR process. The tribe in turn filed a motion requesting that PTAB, an administrative body within the U.S. Patent and Trademark Office, dismiss petitions from three generic drug companies that are trying to use IPRs to invalidate the patents (see “More on Sovereign Immunity”).
CAFC ruled in July that tribal sovereign immunity cannot be asserted in IPR because the proceedings “are both functionally and procedurally different from district court litigation,” and thus more like an agency enforcement action — a situation where tribal immunity does not apply — “than a civil suit brought by a private party.”
In the petition, Allergan and the tribe objected to that classification of IPR, calling it contrary to precedent. The parties wrote that the panel’s decision is inconsistent with the Supreme Court’s decision in SAS Institute Inc. v. Iancu, which held that “IPR is a ‘procedure allow[ing] private parties to challenge previously issued patent claims in an adversarial process before the Patent Office that mimics civil litigation.'”
While the ruling was specific to tribal immunity, the appellants also argue that the precedent could be applied to all cases regarding sovereign immunity because “the panel’s holding turns entirely on the inherent attributes of the IPR proceeding itself,” which are the same for all IPRs.
According to petition, the decision “effectively bars” states and federal agencies such as NASA, HHS, and the U.S. Army and Navy from asserting sovereign immunity in IPRs brought against them as patent owners.
“The panel’s reasoning effectively forecloses IPR immunity claims by any sovereign entity,” the two parties wrote.
Separately on Friday, Mylan N.V. (NASDAQ:MYL), Teva Pharmaceutical Industries Ltd.(NYSE:TEVA; Tel Aviv:TEVA) and Akorn Inc. (NASDAQ:AKRX) filed to extend to Sept. 18 a deadline to provide their response to the en banc petition. The three companies filed suit in the U.S. District Court for the Eastern District of Texas challenging the Restasis patents to launch generic versions of the dry eye drug (see “Conferred Immunity in IPR”).

Zimmer Biomet Hits Another Snag with Warsaw Facility


Zimmer Biomet Holdings Inc. (ZBH) said Monday that a subsidiary got a warning letter from the U.S. Food and Drug Administration last week regarding a manufacturing facility in Warsaw, Ind., the latest snag the company has hit over the same operation in the past couple of years.
The manufacturing facility the FDA has raised issues with is the North Campus manufacturing facility in Warsaw, the same city where Zimmer is headquartered.
“While the warning letter acknowledges our quality remediation plan and actions we’ve already taken to address the FDA’s inspectional observations, it notes violations that require additional action or explanation,” Zimmer said in a securities filing Monday, noting that the FDA wants to meet to “discuss the proposed corrections.”
Zimmer also said in the filing that “the warning letter does not restrict production or shipment of products from the Warsaw North Campus facility or require the withdrawal of any product from the marketplace.”
The FDA issued a Form 483 — a move that is taken if the FDA thinks regulations are being violated — following an inspection it did of the same facility in 2016. The FDA inspected the facility again in April of this year.
Zimmer said that it is “in the process of preparing a written response” to the FDA and that it is planning to reply within 15 days.

Cantex fast-tracked by FDA for leukemia indication


Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals for the treatment of cancer, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation for Cantex’s lead product candidate, CX-01, for the treatment of patients over age 60 receiving induction therapy for newly diagnosed acute myeloid leukemia (“AML”). Earlier this year, the FDA had also granted Orphan Drug Designation to CX-01 for the treatment of AML.
Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug development program with Fast Track Designation is afforded greater access to FDA for the purpose of expediting the drug’s development, review and potential approval.
CX-01 is currently in clinical development for newly diagnosed AML, and refractory myelodysplastic syndrome (“MDS”). CX-01 is designed to block the activity of chemokines that support the resistance of blood cancers to treatment and that contribute to the delay of bone marrow recovery after chemotherapy. Among these chemokines are CXCR4 and CXCL12, which are critical to the attachment of blood cancer cells to the protective bone marrow environment, and platelet factor 4, which slows bone marrow recovery after chemotherapy.
Stephen Marcus, M.D., Chief Executive Officer of Cantex Pharmaceuticals, Inc., commented, “Acute myeloid leukemia (AML) is the most common form of acute leukemia in adults, with approximately 19,500 new cases, more than 60% of which are in people over age 60, estimated in the United States for 2018. Over age 60, the response to initial ‘induction’ therapy is lower, the risk of relapse is higher, and the overall survival is generally shorter, creating a significant unmet medical need for improvement in the effectiveness of this induction therapy.” Dr. Marcus added, “We believe that the award of Fast Track Designation represents recognition of CX-01’s potential to address a significant unmet need in the treatment of AML by enhancing the efficacy of front-line AML chemotherapy. We will work closely with major cancer treatment centers and with the FDA with the goal of bringing CX-01 to patients as quickly as possible.”

Jazz med OKd in EU for leukemia

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission approved Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine.
"Vyxeos is the first chemotherapy to demonstrate an overall survival advantage versus the standard of care in a Phase 3 study of older adult patients with newly diagnosed therapy- related AML or AML with myelodysplasia-related changes," said Daniel Swisher, president and chief operating officer at Jazz Pharmaceuticals. "Jazz is committed to making Vyxeos available to patients in the EU and we will now pursue rolling launches of Vyxeos across the European Union on a country-by-country basis as pricing and reimbursement decisions are made."
The European Commission approval extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.
"AML is a rare cancer in Europe and patients with therapy-related AML or AML with myelodysplasia-related changes have a particularly poor prognosis compared to people with other forms of leukaemia," said Professor Charles Craddock CBE, Academic Director, Centre for Clinical Haematology at University Hospitals Birmingham NHS Foundation Trust. "Vyxeos is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union."
https://bit.ly/2oeIria

Emmaus, Leader in Sickle Cell Treatment, Expands Distribution Via McKesson


Emmaus Life Sciences, Inc. (Emmaus), announces it has entered into a distribution agreement with McKesson Plasma and Biologics LLC (McKesson), a division of McKesson Corporation. The agreement makes Endari™ (L-glutamine oral powder), indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older, available nationwide to pharmacies that utilize McKesson as their primary and exclusive distributor. McKesson is the largest healthcare distribution company in the world.
Since launching Endari, the first U.S. FDA approved sickle cell treatment in 20 years, Emmaus has brought this therapy to patients in over 30 states, Washington DC and Puerto Rico. In addition to the distributors already in place, this agreement with McKesson will further broaden Endari’s distribution, with the potential to reach many more patients suffering from the acute complications associated with sickle cell disease such as pain and frequent hospitalizations.
“As the demand for Endari continues to increase, we seek to build our distribution network to ensure that we reach patients in need,” said Yutaka Niihara, MD, MPH, CEO and Chairman of Emmaus. “Teaming up with a premier distributor like McKesson not only expands our reach but also lends support in establishing Endari as an important treatment option for clinicians fighting this terrible disease.”