New pharmaceutical product to prevent heroin deaths

A new, lifesaving product aimed at reducing the death toll from heroin abuse — developed by a professor at the University of Kentucky College of Pharmacy — is in its final round of clinical trials and has received Fast Track designation by the Food and Drug Administration.

The product, a nasal spray application of the anti-opioid drug naloxone, was developed by Daniel Wermeling, UK professor of pharmacy practice and science, through his startup company AntiOp Inc.

Naloxone is the standard treatment for suspected opioid overdose, already in use by emergency rooms and emergency medical technicians across the country. Opioids are the class of pain-killing drugs that are related to morphine, including prescription drugs such as hydrocodone and oxycodone, as well as illegal drugs such as heroin.
Currently, naloxone is administered by injection. The nasal spray eliminates the need for needles, with a ready-to-use, single-use delivery device inserted into the nose of an overdose victim. The product delivers a consistent dose, absorbed across the nasal membranes even if the patient is not breathing.

“The goal is to make the medication available to patients at high risk of opioid overdose, and to caregivers, including family members, who may lack specialized medical training,” Wermeling said. “The treatment could be given in anticipation of EMS arrival, advancing the continuum of care and ultimately saving lives.”

Nationwide, deaths from opioid overdose are on the rise, according to data from the Centers for Disease Control and Prevention. Kentucky, long troubled by widespread abuse of prescription opioids, has seen a dramatic rise in deaths from heroin overdose in recent years. In autopsies from 2013, the state medical examiner attributed 230 deaths to heroin overdose, an increase of more than 60 percent from the previous year.

UK President Eli Capilouto congratulated Wermeling on his success with AntiOp, saying that it reflects the core values of the university.

“Too many Kentucky families have experienced the tragedy of seeing a loved one’s life cut short by a drug overdose,” Capilouto said. “The epidemic of opioid abuse in our state presents an enormous and urgent challenge, not only for health care providers and law enforcement, but also for us here at the University of Kentucky. Dr. Wermeling’s project is putting a powerful new tool into the hands of those on the front line of the fight against heroin, both here in Kentucky and beyond. This type of innovation embodies the three main components of the university’s mission — education, research and, above all, service.”

UK College of Pharmacy Dean Timothy S. Tracy said Wermeling’s work also provides an illustration of “bench-to-bedside” research in action. “Dr. Wermeling’s project is a great example of how UK College of Pharmacy faculty are working each and every day to create healthier Kentucky communities,” Tracy said. “Dr. Wermeling and his collaborative team of research colleagues saw a problem facing families in Kentucky and across the nation and developed an innovative solution. That type of translational approach is important to our college, this university, and, of course, the future of our Commonwealth.”

Wermeling’s research was supported by a three-year, $3 million grant from the National Institutes of Health through the National Institute on Drug Abuse with additional funding from the Kentucky Science and Technology Corporation. In May, AntiOp partnered with Reckitt Benckiser Pharmaceuticals to accelerate production and worldwide marketing of intranasal naloxone.

The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track-designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
“As an educator, pharmacist, researcher and entrepreneur, being able to work on this naloxone project has been a dream come true,” Wermeling said. “I often tell my students and colleagues that this project has allowed me to use all of the skills I have learned over the years. It has been the ultimate problem-solving project, requiring me to utilize my pharmacological skills, my drug delivery knowledge, my business and marketing skills — all at the same time.

“At the end of the day, however, this project has always been about people. It has always been about utilizing the knowledge and skills that we have to improve patient care.”

A video featuring Dr. Wermeling discussing this work may be viewed online at https://www.youtube.com/watch?v=pgjIH5KkH0k

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Pakistani Clinic ‘Treats’ Drug Addicts With Beatings and Torture

Hashish addict Noor Rehman has spent three years chained to a concrete slab covered by insects.
Beaten and malnourished, he lost his eyesight in a “clinic” run by a Pakistani mullah claiming to cure addicts who were kept against their will and forced to recite the Koran.

“They treated us worse than animals,” the 30-something with a salt and pepper beard muttered among a room full of mullah Maulana Ilyas Qadri’s last remaining patients, all clapped in irons.

When police broke into the clinic last week in Haripur, a city built on a hill around 80 kilometres north of Islamabad, they found 115 ‘patients’ chained in pairs and shackled to the ground.

Most have now been freed and Qadri has been arrested, but around 20, including Noor, are waiting for their families to come and take them home.

The clinic’s methods fall on the more extreme end of the spectrum — even for Pakistan — but offers some insight into how the conservative Islamic nation deals with the taboo subject of drug addiction.

Observers say a lack of legal oversight allows such institutions as well as some mental asylums to become places where families can ‘do away’ with inconvenient relatives.

To prevent inmates from escaping and getting back on to drugs, Qadri left them permanently chained, day and night — except for a few precious moments to go to the bathroom, still chained to their partner.

If they uttered a word of complaint, they were beaten by the mullah and his four guards.

– ‘No therapy, just chains’ –

“They tortured us! By the end of it, patients developed mental issues,” said Noor, who lost his sight eight months ago after two years of confinement.

“It was due to psychological pressure and stress,” he said. Unhygienic conditions where an eye-infection would likely go untreated may have also played a part.

Noor’s brother took him to the centre after discovering his hashish addiction. But he could never imagine himself being imprisoned, let alone becoming handicapped as a result.

Like many other “patients” he blames his family — in this case his brother, who he accuses of leaving him at the centre so he could steal his lands.

Shafiullah, an Afghan refugee with a sinewy physique and bright, turquoise eyes, added: “There was no therapy here, just chains.

“The mullah lets us go out only when he wants our help in construction work. It was us who built these walls,” he said, still chained to a fellow patient.

Others said they were forced to cook and clean in the absence of staff.

Many became addicted to the widespread and — at 50 US cents a hit — cheap drug, with Pakistan a hub for opium smuggled in from neighboring Afghanistan since the 1980s.

Today, Pakistan has more than four million cannabis consumers and more than 860,000 heroin users, a figure which has doubled since 2000 according to a recent UN survey.

Many detoxification clinics offer primitive therapies. Some isolate their patients behind bars — but it is unusual for them to be deprived of their freedom.

– ‘Nothing to do with Islam’ –

A complaint by the family of one patient at Qadri’s clinic led to a police raid and his downfall. Locked up at Haripur police station, the incarcerated mullah continued to defend his controversial methods, even as he faces the prospect of jail time for torture and illegal confinement.

“I recite the Koran, then blow on water and give this water for drinking three times a day. Normally the addicts who stop using have the tendency to vomit and shake. But thanks to the Surah Yassin (a verse) they don’t have problems,” said the self-proclaimed healer.

“And then one week, without any medicine, they are better. Even in the top institutions you will never see this,” he boasted, while calling himself a victim of police corruption for failing to pay them a bribe.

“He chained us and beat us with a stick. This has nothing to do with Islam,” responded ex-patient Shafiullah.

The controversial mullah was previously arrested in 2006 for imprisoning patients in his clinic. But he was released under bail and then acquitted.

He then re-opened his centre where his shock therapy costs each family Rs8000 ($80) per month.

During family visits, patients were instructed to say “everything is okay, else they would be beaten” said Mehboob Khab, head of the police station where the Mullah is jailed.

But his controversial methods also found approval among many families.

“When he’s chained up, my son cannot escape. These chains are doing him good, and on top of it he has learnt to recite the Koran,” said a man called Sultan, who was outraged by the closure of the centre.

Niaz, who came to pick up his brother Lutuf, said the treatment was necessary. “My brother needed this severe treatment. Without it he would get back on the drugs.”

Lutuf stared blankly into space for a moment before responding.

“My brother doesn’t know the whole story. I know what happened here.”