One-fourth of doctors not confident they can safely get patients off opioids

While 86% of physicians agreed that helping people get off of opioids is a fundamental part of stopping the country’s epidemic, a quarter of them say they aren’t confident they can safely get patients off the addictive drugs.
Some 80% of physicians say there is a lack of education about how to help their patients stop taking opioid painkillers, according to a new national survey from US WorldMeds that asked both doctors and consumers about barriers to ending the opioid crisis.

Both agreed a lack of education around how to discontinue opioids is a huge barrier to the epidemic which the Centers for Disease Control and Prevention (CDC) says has resulted in the deaths of more than 200,000 Americans from prescription opioid overdoses since the addiction crisis began in the late 1990s.
According to the survey, 86% of physicians and 88% of the American public agree that helping people get off of opioids should be a fundamental part of addressing America’s opioid crisis. However, nearly a quarter of physicians are not confident they can safely get patients off of opioids.
Some 76% of physicians say that fear of opioid withdrawal is keeping patients from getting off of opioids.

The survey conducted in June included 500 physicians and 1,100 U.S. adults. “Physicians and patients are overwhelmingly asking for more education around stopping opioids,” said P. Breckinridge Jones, CEO and founder of US WorldMeds, a specialty pharmaceutical company based in Louisville, Kentucky.
Both the CDC and the Food and Drug Administration earlier this year warned prescribers that abruptly cutting off high-dose patients or tapering their doses of opioids too rapidly could cause withdrawal and even suicide.

https://www.fiercehealthcare.com/practices/one-fourth-doctors-not-confident-they-can-safely-get-patients-off-opioids

GlaxoSmithKline and Innoviva look for new Trelegy use

GlaxoSmithKline (NYSE:GSK) and Innoviva (NASDAQ:INVA) announce the filing of a supplemental new drug application to the FDA for an additional indication for the use of Trelegy Ellipta for asthma in adults.

The companies note Trelegy Ellipta was approved in the U.S. in 2017 for the treatment of patients with chronic obstructive pulmonary disease.

Source: Press Release

https://seekingalpha.com/news/3503328-glaxosmithkline-innoviva-look-new-trelegy-use

Sarepta competitor files with FDA for Duchenne drug

Sarepta Therapeutics (NASDAQ:SRPT) -3% pre-market after Japanese drugmaker NS Pharma said it filed with the U.S. Food and Drug Administration to seek approval for its new drug to treat Duchenne muscular dystrophy.

If approved, the NS Pharma drug would be the first treatment for children born with Duchenne caused by a mutation in the DNA.

In August, the FDA raised concerns about SRPT’s New Drug Application seeking accelerated approval of golodirsen injection for treatment of DMD.

https://seekingalpha.com/news/3503331-sarepta-competitor-files-fda-duchenne-drug

Veeva acquires Crossix, pairing doctor, patient data and marketing services

Veeva Systems is buying Crossix Solutions with an eye to integrating the Veeva healthcare professional (HCP) cloud software services with the more patient-centric Crossix data and analytics.
Under the $430 million cash deal, Crossix will remain an independent unit inside Veeva called Veeva Crossix and will continue to be run by Crossix CEO Asaf Evenhaim.
Crossix’s data—both health and non-health—come from 300 million patients in the U.S. and include prescription, OTC, clinical, claims and hospital data to help inform pharma marketing initiatives. Crossix said more than 200 pharma brands use its services.

Paul Shawah, Veeva senior vice president of commercial strategy, said the deal makes sense, as Veeva and Crossix grew up together in adjacent markets—with life science professionals for Veeva building communication channels for field reps, and with patients for Crossix building out data, analytics and privacy for pharma marketers.
He said while it’s still early, the potential and power is in combining the two.
“What we’ll be able to do is link patient data to healthcare professionals, so you start to better target HCPs based on the patients that they actually treat,” he said.
That leads to the potential for integration or cross-sharing data to do things like match patient activity data with patient data and outcomes, study cause-and-effect relationships and enhance custom reference data to better target and serve patients.

Evenhaim agreed and offered an example of how the integration can boost both sides’ offerings.
“When marketing managers, for example, look to optimize a digital media camp, they can look at how the advertising is doing in terms of getting new patient starts, but also look at how much of that is prescribed by physicians the field force recently called on versus physicians that have not been called on,” he said. “That kind of insight, that ability to integrate the patient and the HCP and sales and marketing, is pretty powerful.”
https://www.fiercepharma.com/marketing/veeva-acquires-patient-data-and-analytics-specialist-crossix-pairing-hcp-and-patient-data

Drug companies urge appeals court to remove judge from U.S. opioid litigation

Eight drug companies on Tuesday urged a federal appeals court to disqualify the judge overseeing nationwide opioid litigation, in a last-ditch effort to avoid having him preside over a landmark trial in three weeks.

The request came six days after U.S. District Judge Dan Polster in Cleveland refused to recuse himself and said he had done nothing to favor the state and local governments suing for damages, including by encouraging settlements.
But the eight pharmacy chains and drug distributors told the 6th U.S. Circuit Court of Appeals in Cincinnati that Polster has “lost sight” of his responsibility to appear unbiased, including by acknowledging a “personal mission” to address the opioid crisis.
Polster oversees more than 2,300 of the roughly 2,600 lawsuits brought by state, local and tribal governments, hospitals and other entities seeking to hold the drug industry responsible for the toll of opioid abuse.
The scheduled Oct. 21 trial is the first in a federal court.

Ohio’s Cuyahoga and Summit counties, the only plaintiffs, want $8 billion of damages, according to the eight companies.
“The time for disqualification is now,” the companies said.
They added that removing Polster would help preserve “public confidence in the integrity of the judicial system. That should be a special imperative in this litigation, which is so much in the public eye.”
The companies include retailers CVS Health Corp, Rite Aid Corp, Walgreens Boots Alliance Inc and Walmart Inc, and distributors AmerisourceBergen Corp, Cardinal Health Inc, Henry Schein Inc and McKesson Corp.
Their disqualification request, originally made directly to Polster on Sept. 14, followed several rulings against them.
Legal experts have called the effort to remove Polster a long shot, saying it is common for judges to encourage settlements and that disqualifications are rare.
Ohio, 13 other states and Washington, D.C. have separately asked the appeals court to halt the upcoming trial, saying it undermines their right to litigate on their own.
Opioid addiction claimed roughly 400,000 lives in the United States from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention.
https://www.reuters.com/article/us-usa-opioids-litigation/drug-companies-urge-appeals-court-to-remove-judge-from-u-s-opioid-litigation-idUSKBN1WG4IP

Savara slides 50%-plus after FDA rejects Molgradex

Savara (NASDAQ:SVRA) -57.6% pre-market after the Food and Drug Administration said data on the development program for the company’s Molgradex lung disease treatment do not provide sufficient evidence of efficacy and safety.

SVRA says the FDA did not recommend submission of a Biologics License Application for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor.

The company says it remains “committed to the Molgradex development program and believe that it will provide aPAP patients with a meaningful treatment option.”

https://seekingalpha.com/news/3503310-savara-slides-50-percent-plus-fda-rejects-molgradex

PTC Therapeutics Risdiplam Spinal Muscular Atrophy Data Continues Benefit

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced data demonstrating the ongoing benefit of risdiplam (RG7916) for the treatment of all types of spinal muscular atrophy (SMA) at the 24th International Annual Congress of the World Muscle Society. Presentations include data from the FIREFISH, SUNFISH, and JEWELFISH clinical trials. The SMA program is a collaboration between PTC, the SMA Foundation, and Roche.
“We are excited that risdiplam has the potential to enter the market with a best-in-class profile for patients with all types of SMA,” said Stuart W. Peltz, Ph.D., Chief Executive Officer of PTC Therapeutics. “These data continue to demonstrate the disease-modifying properties of risdiplam across a broad range of ages and infants receiving the drug are continuing to experience improved motor outcomes.  Importantly, these results help validate PTC’s splicing platform that is currently being used in other programs.”
Data from Part 1 of the FIREFISH clinical trial demonstrated that after 16 months of treatment, 82% (14/17) of high-dose patients had a CHOP-INTEND score ≥40. 86% (18/21) of all infants were event-free after receiving risdiplam for 16 months. No infant has required tracheostomy or reached permanent ventilation. The primary objective of FIREFISH Part 1 was to assess the safety profile of risdiplam in infants and determine the dose for Part 2.
In patients in Part 1 of the SUNFISH clinical trial, risdiplam treatment led to a median two-fold increase in blood SMN protein levels after four weeks of treatment, sustained for at least 12 months. In the natural history cohort, patients did not experience any change in SMN protein levels over the same period. Patients receiving risdiplam in SUNFISH Part 1 showed a clinically meaningful increase in total MFM32 score including a broad range of ages and functional status at baseline compared with natural history, independent of age and disease severity. SUNFISH Part 1 is focused on the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy in patients with type 2 or 3 SMA between 2 and 25 years old.
Data from 45 patients in the JEWELFISH trial demonstrated a sustained, greater than two-fold increase in median SMN protein versus baseline over 12 months of treatment. Patients in the JEWELFISH study have previously been treated with nusinersen or other therapies.

https://www.marketscreener.com/PTC-THERAPEUTICS-INC-13450034/news/PTC-Therapeutics-Risdiplam-Spinal-Muscular-Atrophy-Data-Demonstrating-Continued-Benefit-Presented-29325589/