Valerie Fuoco has been coping with severe physical pain all her life.
Like so many Americans in her situation, Fuoco has also become addicted to prescription opioids.
Fuoco is a 36-year-old computer analyst from Virginia, and a married mother of two small children.
Because of brain swelling and other serious health issues that began at birth, she has undergone some 30 surgeries. The first one was when she was only four days old.
“I remember one where they had to go through my neck, cut the muscles, and push the brain back up. It hurt so badly. Pain has been a lifelong issue for me," Fuoco told Healthline.
Doctors began prescribing opioid pain medication for Fuoco when she was a freshman in high school.
In college, the problem escalated and she found herself running through a monthly dose of pain medication in a week or two, then turning to alcohol until she got her next prescription.
In 2007, she said her life was hanging in the balance.
“I called my mom. I told her I needed help, that I could not go on like this,” recalled Fuoco, who has never used illegal drugs.
With her mother’s help, Fuoco found a treatment center and stayed there for three months on both an in-patient and out-patient basis.
“That’s when I was first put on Suboxone,” she said.
Suboxone, which contains buprenorphine, is an opioid medication that helps relieve symptoms of opiate withdrawal.
It’s used as part of an addiction treatment program that typically also includes counseling, lifestyle changes, and other interventions.
Fuoco had taken the medication orally every day for the past eight years.
But a month ago, she agreed to begin receiving the drug in a novel and groundbreaking way.
While discussing options to help wean her off daily medication, Fuoco’s doctor told her Suboxone could be released into her bloodstream on a slow, safe, and steady basis.
A Probuphine implant was inserted into her arm in a minimally invasive procedure. The implant supplies her body with buprenorphine via four soft, flexible, one-inch matchstick-sized rods.
The implant, which is the first buprenorphine implant for the maintenance treatment of opioid dependence, distributes the medication into the bloodstream for six months.
It is advantageous for multiple reasons, proponents say.
Implanted, long-acting medications can provide people with psychological support in recovery since they're not reminded of their condition by a daily pill.
Controlled release of implanted drugs can also enhance efficacy.
It can also help older adults who may be more likely to forget to take their medications.
And, it’s a simple procedure that can be done in just minutes in a doctor’s office.
Fuoco said the implant gives her a great sense of comfort knowing that she will never forget a dose, or be able to abuse the drug.
She feels steadier and calmer, and said that perhaps the best part is that her two young children, ages 10 months and 3 years, “will never have access to these medications, which would be scary.”
Training for implant process
According to Braeburn Pharmaceuticals, more than 2,600 healthcare providers have been trained to implant and/or prescribe Probuphine.
These include mostly doctors but also physician assistants and nurse practitioners.
While most healthcare providers seek training to implant and prescribe Probuphine, not all are trained to do both. In these cases, healthcare practitioners work together to treat patients.
For example, a psychiatrist would prescribe the Probuphine implant to a patient, and a trained nurse practitioner would perform the implantation.
“Our vision is to provide a continuum of care that allows personalized treatment of opioid addiction where noncompliance can lead to overdose and oftentimes death,” Mike Derkacz, president and chief executive officer of Braeburn, told Healthline.
Derkacz said long-acting therapies free people from the burden of taking their medication daily by providing ongoing protection from the symptoms of their disease.
He added that Braeburn is developing several innovative therapies that are administered to patients in a range from once weekly to once every six months, “to better meet the addiction treatment needs of patients, physicians, and payers.”
Trend taking off
The emergence of drug implants is not limited to addiction treatment.
The implants market started humbly and slowly with contraceptive implants for women, such as Nexplanon, Implanon, and Norplant, as well as testosterone implants.
But this new method of administering drugs is an option for a growing variety of people battling numerous illnesses, including life-threatening diseases.
It hasn't yet revolutionized medicine. But it likely will, soon, at least for some patients, many healthcare industry observers say.
Indeed, the National Institutes of Health (NIH) and other prestigious health and research organizations are funding drug implant trials and studies.
The Bill and Melinda Gates Foundation, for example, is investing up to $140 million in the creation of the so-called Medici implant that can continuously release the HIV drug PrEP.
This implant, which is being developed by Intarcia Therapeutics in Boston, works up to one year without requiring a replacement.
Emilio Emini, director of the Gates Foundation’s HIV programs, told the Huffington Post earlier this year that the implant could be particularly helpful for people in Sub-Saharan Africa, where the HIV and AIDS burden is profound.
“HIV continues to represent a substantial infectious disease burden, with some of the highest rates of infection among young people living in Sub-Saharan Africa. Currently there is no effective HIV vaccine, and antiretroviral drugs that protect against HIV infection are only available in the form of a daily pill,” Emini said.
Intarcia’s implantable Medici drug delivery system, which could be used to deliver long-acting antiretroviral drugs, “has the potential to solve current adherence challenges and help more people protect themselves from HIV infection,” Emini said.
People with diabetes stand to benefit
There’s also a significant amount of drug implant research being done on people with diabetes.
Just a few weeks ago, Delpor Inc., a San Francisco-based biotechnology company focused on drug delivery, received a $1.5 million grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a wing of the NIH.
The grant will enable Delpor to advance its implant drug delivery system, DLP-414, for the drug exenatide, which is used to treat type 2 diabetes.
Tassos Nicolaou, president and chief executive officer of Delpor, noted that approximately 10 percent of adults in the United States have diabetes, and that the Centers for Disease Control and Prevention (CDC) projects as many as 1 in 3 could have diabetes by 2050.
“DLP-414 will provide a “safer, more efficacious, cost effective, and less invasive maintenance therapy for patients suffering from type 2 diabetes, and the further validation of the proposed technology will create the potential for a safer, and more convenient delivery of proteins and peptides,” Nicolaou said in a press statement.
While drug implants are not for everyone, or for every drug, he added, “they will have a big impact on medicine. Implants are something that I believe can provide tremendous clinical benefit for many patients.”
Nicolaou explained current implants will only work for drugs that require relatively low doses.
“For something that requires you to take 50 milligrams per day, you’d need a huge implant. It would not work,” he said. “But for drugs where doses are 2 to 3 milligrams a day, it is doable.”
Mental health applications
In March, Delpor announced the issuance of a U.S. patent covering its drug implant technology for antipsychotics and other drugs.
Delpor has several products in development, including a six-month formulation of risperidone and a three-month formulation of olanzapine, drugs that are both used for schizophrenia maintenance treatment.
“Almost half of the patients who are taking antipsychotics are not taking their medication and are relapsing,” Nicolaou said. “It’s not that they don’t want to take their medicine, they just don’t always have the cognitive skills to do this daily. So an implant for this is a no-brainer in terms of patient value.”
On the diabetes side, he said, drug implant delivery is also a no-brainer.
“You can get benefit delivering it in steady fashion, as opposed to the spikes that come with injection,” he said.
Nicolaou said drug implants are certainly not for everybody.
But, he noted, “The potential uses for drug implants will generate enough of a list that it could be in the billions of dollars. Diabetes alone is one of fastest growing areas, with a patient population that is getting older.”
Nicolaou said the NIH has been invaluable in lifting this sector up and getting it where it should be.
“I feel a deep gratitude to the NIH,” he said. “We are very close to moving forward with products that will have a huge impact on patients, and it would not have been possible without support from NIH.”
With all the talk by the Trump administration proposing a 20 percent cut to the NIH budget, Nicolaou said, “People need to know that the NIH is crucial in terms of new innovation and to help companies bridge the gap from research to the clinic.”
In addition to opioid addiction, HIV, diabetes, and psychotropic drugs, other potential uses include antibiotics and oncology drugs.
There are a few downsides to implanted drugs, but not many, proponents say.
Some can be irritating to tissue, for example.
And when you need to have the implant removed, for whatever reason, the only way to remove it is with the help of a physician or someone else who is trained to remove it.
When it comes to opioid addiction medications, specifically, it is possible to overdose when combining buprenorphine and large amounts of alcohol, sedatives, tranquilizers, or other drugs that slow breathing.
But Fuoco and other people interviewed for this story — several who wished not to be named — said they are all for the buprenorphine implant.
Using tragedy to help others
Dr. Alan Geringer, a urologist from Maryland, switched the emphasis of his work and life after a personal family tragedy.
Geringer’s stepdaughter, Chelsea, who was fighting addiction, died of an accidental overdose.
His other stepdaughter, Jenna, came close to death from opioid addiction, but has since recovered.
“Chelsea was just 22 when she died,” Geringer told Healthline. “The family was not aware she had a problem.”
As a result of Chelsea’s death and Jenna’s near-death experience, Geringer took the training required to treat people with buprenorphine and the Probuphine implant, and has since helped many people in their efforts to recover from addiction by prescribing the drug implants.
“It has given me the opportunity to potentially save a life, perhaps somebody’s daughter, somebody in your family,” Geringer said. “I’m not an addict, but this has hit me personally.”
When it comes to opioid addiction, specifically oxycodone or heroin addiction, Geringer said people have a few options.
But Geringer prefers the drug implants.
“It’s really simple to put it in. I can do it in my office. It’s not surgery, it’s a very simple procedure,” he said. “There are special instruments to make it simple to do.”
He said there are a number of reasons why it is a good option for treating addiction.
“With this method there is no worry about losing the medication, or about abusing the medication,” Geringer said.
He added the product is approved for people who are stable and have been on a low, steady dose of the drug beforehand for at least three months.
Geringer said drug implants for opioid addiction treatment should appeal to insurance companies.
“The unknown factor in the drug implant trend for the treatment of addiction is the obvious: insurance paying for these things. When you are talking about buprenorphine, it is still new, just one year old,” he said.
“It’s just a matter of convincing insurance companies to do it. It’s still at times a little battle to get it approved. But if you are concerned that people are abusing these drugs, you cannot abuse this to get high when it is an implant, you cannot sell it to your friends. The abuse issue is one thing that is solved,” he said.
“Secondly, if the goal of course is to make people feel normal and live a normal life, well, this takes out of the equation the ups and downs of addicts who need to medicate all the time. It makes their life more normal.”
Geringer said that while his stepdaughter Jenna relapsed after her baby was born, he said, “I went with her to an AA meeting to celebrate her two years being clean. She spoke at the AA meeting, I spoke afterward. My message was: Believe in miracles because Jenna is a miracle. I never thought she could do as well, it’s hard work. Jenna was catalyst in starting me on this addiction medicine path.
Getting on with her life
Meanwhile, Fuoco looks forward to continuing her busy life, working and chasing after her two kids, and taking comfort knowing she is receiving steady treatment.
And while doctors have told her that taking an opioid antagonist could be a lifelong thing, she hopes to eventually try to taper down and ultimately get off the medication.
After the six-month course of treatment, the Probuphine implant is removed. Each patient will then work with their doctor to determine the next steps for treatment.
A spokesperson for Braeburn said some people have received a second implant in their opposite arm as part of the company’s open label study, and it has proven to be safe and effective.
Braeburn is conducting post market studies to determine the feasibility of ongoing treatment with Probuphine, said the spokesperson, including inserting the implant in the same arm as the first course of treatment.
“I would like to eventually lower the dose,” Fuoco said. “If that is an option, I would do it, and keep lowering it, taper down.”
“I hope insurance companies really take this up. My insurance is good about not putting limitations or denying this,” she said, adding that she knew that some doctors have had trouble getting insurance to cover this.
“To get this covered by insurance, patients really have to become their own advocate,” she said.”
And while she said she’s not an activist, she wants people to know this drug implant option exists. Because she thinks it could save lives.