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NOVA Addiction Specialists website – Suboxone and telemedicine treatment in Alexandria, Virginia 703-844-0184

Dr. Sendi – at NOVA Addiction Specialists can evaluate you to see if Sublocade will work for you.

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Suboxone treatment in Alexandria, Virginia 703-844-0184

Suboxone treatment in Fairfax, Virginia 703-844-0184


Suboxone, buprenorphine telemedicine treatment in Alexandria  << Link here

http://addictiondomain.com/ Addiction Blog

https://www.facebook.com/novaddiction – Facebook page


http://www.suboxonecenter.org/ Suboxone treatment – telemedicine also – 703-844-0184 24/7


I’m posting two totally unrelated items. One is a link to anti-inflammatory recipes I found to be pretty good. Then below is a link to Pharmacy Times article regarding Sublocade, the new once-a-month injectable version of Suboxone.

Anti-inflammatory Dinner Recipes

20 Easy Anti-Inflammatory Dinner Recipes That Will Make You Feel Great


Sublocade for Opioid Use disorder

Sublocade for Opioid Use Disorder: What Pharmacists Should Know

JANUARY 01, 2018

The United States is in the middle of an opioid abuse epidemic. Since 1999, the number of overdose deaths involving opioids has quadrupled and currently an estimated 91 Americans die every day from an opioid overdose.1 Over recent years, an emphasis has been placed on the role of medication-assisted treatment (MAT) combined with psychosocial support to combat the growing opioid epidemic.

In November 2017, the FDA approved Indivior’s Sublocade, an extended-release buprenorphine injection for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product. With its approval, Sublocade became the first once-monthly buprenorphine injection for the treatment of OUD.

This article highlights several key therapeutics areas with Sublocade that every pharmacist should know.

Sublocade contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of moderate-to-severe OUD in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.

Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support.

Limitations of Use
The safety and effectiveness of Sublocade have not been established in pediatric patients.

Additionally, Sublocade is not appropriate for use in opioid naïve patients or for treatment where Sublocade would be the first buprenorphine product used.

Mechanism of Action
Sublocade contains an extended-release formulation of buprenorphine, which is a partial agonist at the mu opioid receptor and an antagonist at the kappa opioid receptor. Buprenorphine displays high affinity at these receptions and therefore is not easily replaced by other opioids.

Formulation and Storage
Sublocade is available as a sterile, clear solution in a single dose, prefilled syringe with safety needle. It is available in 2 formulations: 100 mg/0.5 mL and 300 mg/1.5 mL.

It should be stored in refrigeration at 2 to 8°C (35.6 to 46.4°F). Once outside the refrigerator it may be stored in its original packaging at room temperature for up to 7 days prior to administration. If left at room temperature for longer than 7 days Sublocade should be discarded.

Medication Availability
Only health care providers should prepare and administer Sublocade. Additionally, Sublocade is subject to a risk evaluation and mitigation strategy (REMS) program that includes a restricted distribution system to ensure that Sublocade is only administered by a healthcare provider. Therefore, this is not a medication that would typically be dispensed through retail pharmacy.

The recommended dose of Sublocade following induction and dose adjustment with transmuscosal buprenorphine is 300 mg monthly by subcutaneous injection in the abdominal region for the first 2 months followed by a maintenance dose of 100 mg monthly.

The maintenance dose may be increased to 300 mg monthly for patients who tolerate the 100 mg dose, but do not demonstrate a satisfactory clinical response, as evidenced by self-reported illicit opioid use or urine drug screens positive for illicit opioid use.

A patient who misses a dose should receive the next dose as soon as possible, with the following dose given no less than 26 days later. Occasional delays in dosing up to 2 weeks are not expected to have a clinically significant impact on treatment effect.

Notably, Sublocade is only appropriate in adults who have initiated treatment on a transmucosal buprenorphine-containing product delivering the equivalent of 8 to 24 mg of buprenorphine daily. The patient may only be transitioned to this medication after a minimum of 7 days. Initiating treatment with Sublocade as the first buprenorphine product has not currently been studied.

The efficacy of Sublocade for the treatment of moderate to severe OUD was established in a phase 3 double-blind study and an opioid blockage study.

The phase 3 study was a 24-week, randomized, double-blind, placebo-controlled, multicenter trial in treatment-seeking patients who met the DSM5 criteria for moderate or severe OUD. Patients were randomly assigned to one of following dosing regimens: 6 once-monthly 300 mg doses, 2 once-monthly 300 mg doses followed by 4 once-monthly 100 mg doses, or 6 once-monthly SC injections of placebo. All patients received psychosocial support at least once a week. Prior to the first dose, treatment was initiated with Suboxone (buprenorphine/naloxone) sublingual film with doses adjusted from 8/2mg to 24/6 mg per day over a period of 7 to 14 days. Efficacy was evaluated over weeks 5 through 24 based on weekly urine drug screens combined with self?reported use of illicit opioid use.

A total of 504 patients were randomized into the study. Based on the cumulative distribution function (CDF) of the percentage of urine samples negative for illicit opioids combined with self-reports collected from week 5 through week 24, regardless of dose, Sublocade was statistically superior to the placebo group. Additionally, the proportion of patients achieving treatment success (defined as patients with ≥80% opioid?free weeks) was statistically significantly higher in both groups receiving Sublocade compared to the placebo group (28.4% [300 mg/100 mg], 29.1% [300 mg/300mg], 2% [placebo]).

The opioid blockage study evaluated the blockage of subjective opioid effects, pharmacokinetic, and safety of Sublocade in 39 patients with OUD. In the study, the average buprenorphine plasma concentrations of 2-3 ng/mL were associated with mu-opioid receptor occupancy ≥70%. Additionally, Sublocade was shown to be non-inferior to hydromorphone injections in terms of “drug liking.”

The most common adverse reactions of Sublocade reported in clinical trials include constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.

Sublocade has a boxed warning noting that serious harm or death could result if this medication is administered intravenously. Other warnings and precautions in the prescribing information include a risk of addiction, abuse, and misuse, respiratory depression, adrenal insufficiency, hepatic events, and opioid withdrawal with abrupt discontinuation.

Drug interactions
Benzodiazepines and other central nervous system (CNS) depressants should be used with caution due to an increased risk of respiratory depression. Patients taking CPY3A4 inhibitors and substrates should be closely monitored for potential over- or under-dosing.

Product Comparison3

Indication Administration Frequency Generic Available4
Sublocade (buprenorphine) Opioid dependence SQ Injection Monthly N
Probuphine (buprenorphine) Opioid dependence Intradermal implant 6 months x 1 dose N
Suboxone (buprenorphine and naloxone) Opioid dependence Sublingual tablet and film Daily Y (tablet), N (film)
Subutex (buprenorphine) Opioid dependence Sublingual tablet Daily Y
Zubsolv (buprenorphine and naloxone) Opioid dependence Sublingual tablet Daily N
Bunavail (buprenorphine and naloxone) Opioid dependence Buccal film Daily N
Buprenex (buprenorphine) Pain IM or IV injection Varies Y
Belbuca (buprenorphine) Pain Film Twice daily N
Butrans (buprenorphine) Pain Transdermal patch 7 days on, 3 weeks off N

In clinical studies, Sublocade was shown to be effective in reducing illicit opioid use as compared to placebo and block ≥70% of mu-opioid receptors. Sublocade was relatively well-tolerated with most adverse effects attributed to injection site reactions and other effects common to all buprenorphine products. Sublocade is advantageous as a once monthly injection which can help remove the burden and decision of having to take another buprenorphine medication on a day-to-day basis. For some people, this may help improve adherence. Although Sublocade is the first once-monthly buprenorphine injection for the treatment of OUD another long-acting buprenorphine product, Probuphine, has been available on the market since 2016. Head to head studies would be beneficial to compare the efficacy of Sublocade versus other buprenorphine containing products.


  1. Understanding the Epidemic. CDC. https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed December 15, 2017
  2. Sublocade [Prescribing Information]. Indivior Inc. North Chesterfield, VA. November 2017.
  3. Lexicomp Online®, Lexi-Drugs®, Hudson, Ohio: Lexi-Comp, Inc.; December 15, 2017.
  4. Electronic Orange Book. Food and Drug Administration. Available at: http://www.fda.gov/cder/ob/default.htm/. Accessed December 20, 2017


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NOVA Addiction Specialists website – Suboxone and telemedicine treatment in Alexandria, Virginia 703-844-0184

Dr. Sendi – at NOVA Addiction Specialists can evaluate you to see if Sublocade will work for you.

NOVA Addiction facebook page

Suboxone treatment in Alexandria, Virginia 703-844-0184

Suboxone treatment in Fairfax, Virginia 703-844-0184


Suboxone, buprenorphine telemedicine treatment in Alexandria  << Link here

http://addictiondomain.com/ Addiction Blog

https://www.facebook.com/novaddiction – Facebook page


http://www.suboxonecenter.org/ Suboxone treatment – telemedicine also – 703-844-0184 24/7



Blocking microglial pannexin-1 channels alleviates morphine withdrawal symptoms

Opiates are essential for treating pain, but termination of
opiate therapy can cause a debilitating withdrawal syndrome
in chronic users. To alleviate or avoid the aversive symptoms
of withdrawal, many of these individuals continue to use
opiates1–4. Withdrawal is therefore a key determinant of opiate
use in dependent individuals, yet its underlying mechanisms
are poorly understood and effective therapies are lacking. Here,
we identify the pannexin-1 (Panx1) channel as a therapeutic
target in opiate withdrawal. We show that withdrawal from
morphine induces long-term synaptic facilitation in lamina I
and II neurons within the rodent spinal dorsal horn, a principal
site of action for opiate analgesia. Genetic ablation of Panx1
in microglia abolished the spinal synaptic facilitation and
ameliorated the sequelae of morphine withdrawal. Panx1
is unique in its permeability to molecules up to 1 kDa in size
and its release of ATP5,6. We show that Panx1 activation
drives ATP release from microglia during morphine withdrawal
and that degrading endogenous spinal ATP by administering
apyrase produces a reduction in withdrawal behaviors.
Conversely, we found that pharmacological inhibition of
ATP breakdown exacerbates withdrawal. Treatment with
a Panx1-blocking peptide (10panx) or the clinically used
broad-spectrum Panx1 blockers, mefloquine or probenecid,
suppressed ATP release and reduced withdrawal severity.
Our results demonstrate that Panx1-mediated ATP release
from microglia is required for morphine withdrawal in rodents
and that blocking Panx1 alleviates the severity of withdrawal
without affecting opiate analgesia. 

Could This Inexpensive Medication Reduce Your Withdrawal Symptoms?

Could This Inexpensive Medication Reduce Your Withdrawal Symptoms?

Withdrawal. It’s a huge hurdle on the path to recovery.

Those struggling to leave opioids behind know they’ll eventually have to face the intimidating mental and physical effects of withdrawal. It’s a powerful and frightening thought.

Some of the most common withdrawal symptoms include:

  • Muscle aches and cramps
  • Nausea, vomiting, and diarrhea
  • Anxiety, profuse sweating, and restlessness
  • Blurry vision
  • High blood pressure

Help Where It’s Needed Most

Even though millions of Americans are in the midst of this battle, few medications are available to effectively manage their symptoms. This unavailability – and the onset of painful withdrawal symptoms – are often enough to make many people give up and return to opioids for relief.

But this could soon change…

According to the results of a recent study, help for intense withdrawal symptoms might be on the horizon, thanks to the discovery of a new drug.

“Opioid withdrawal is aversive, debilitating, and can compel individuals to continue using the drug in order to prevent these symptoms,” explains lead researcher Tuan Trang, PhD.

“In our study, we effectively alleviated withdrawal symptoms in rodents, which could have important implications for patients that may wish to decrease or stop their use of these medications.”

The Study

Researchers from the University of Calgary’s Faculty of Veterinary Medicine and Hotchkiss Brain Institute investigated the process of withdrawal and its’ possible causes. The study involved rats which had been given two potent opioids, morphine and fentanyl. The team identified the glycoprotein, pannexin-1, as the source of withdrawal symptoms in rodents. Pannexin-1 is also located throughout the human body, including the brain and spinal cord.

After identifying the cause of these symptoms, the team tested a drug already proven to block the effects of pannexin-1 called, Probenecid. It’s an anti-gout medication that’s fairly cheap and has few side effects.

The results showed this medicine was “effective in reducing the severity of withdrawal symptoms in opioid-dependent rodents.” Another encouraging aspect about their findings: the medication didn’t affect an opioids’ ability to relieve pain.

Previous research hadn’t explored this avenue, and this investigation has provided a better understanding of opioid withdrawal at the cellular level.

The Implications

Canadian pain researcher, Dr. Michael Salter, notes, “This is an exciting study which reveals a new mechanism and a potential therapeutic target for managing opioid withdrawal. The findings of Dr. Trang and his team could have important implications for people on opioid therapy and those attempting to stop opioid use.”

The team behind the study plan to continue their work and hope this new insight will lead to the creation of a more effective treatment method for the symptoms of withdrawal. Dr. Trang says their next steps will be to determine the drug effectiveness in humans and to ensure its’ safety. Their goal is to develop an effective method to treat the millions struggling with pain management and opioid dependency across the nation and around the world.

These results have already lead to the development of a clinical trial at the Calgary Pain Clinic.


FDA approves first medication to reduce opioid withdrawal symptoms


May 16, 2018

LofexidineCourtesy of US WorldMeds, LLC.

The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, is pleased to announce that lofexidine, the first medication for use in reducing symptoms associated with opioid withdrawal in adults, has been approved by the U.S. Food and Drug Administration. Lofexidine, an oral tablet, is designed to manage the symptoms patients often experience during opioid discontinuation. Opioid withdrawal symptoms, which can begin as early as a few hours after the drug was last taken, may include aches and pains, muscle spasms/twitching, stomach cramps, muscular tension, heart pounding, insomnia/problems sleeping, feelings of coldness, runny eyes, yawning, and feeling sick, among others. The product will be marketed under the brand name LUCEMYRATM.

In 2016, more than 42,000 people died from an opioid overdose, or approximately 115 people per day. Although effective treatments exist for opioid addiction, painful and difficult withdrawal is one of the reasons treatment fails, and relapse occurs. By alleviating symptoms associated with opioid withdrawal, LUCEMYRA could help patients complete their discontinuation of opioids and facilitate successful treatment. To date, no other medications have been approved to treat opioid withdrawal symptoms.

LUCEMYRA will be marketed by US WorldMeds, a specialty pharmaceutical company that acquired a license for lofexidine from Britannia Pharmaceuticals in 2003. NIDA provided funding to US WorldMeds to support clinical trials to document the clinical pharmacokinetics of lofexidine and to test medical safety and efficacy of the medication, as compared to a placebo, among patients undergoing medically supervised opioid discontinuation. LUCEMYRA is expected to be commercially available in the United States in August 2018.

Read FDA press release: FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

Read NIDA Director Dr. Nora Volkow’s blog: NIDA-Supported Science Leads to First FDA-Approved Medication for Opioid Withdrawal

For more information about opioids, go to the Opioids webpage. For information about treatment approaches for drug addiction, go to Treatment Approaches for Drug Addiction.

Medication for Opioid Withdrawal


May 16, 2018

Image of drug Lucemyra (Lofexidine)Courtesy of US WorldMeds, LLC

In 2016, 115 Americans died every day from an overdose involving prescription or illicit opioids. Addiction to any drug has multiple components—altered functioning of the reward system, learned associations with drug cues that promote preoccupation and craving, and changes to prefrontal circuits necessary for proper exertion of self-control. But physiological and psychological withdrawal symptoms play a major role in driving users repeatedly back to the drug, despite efforts to stop using.

Withdrawal is notoriously hard to endure for people addicted to opioids. Physical symptoms can start a few hours after last taking the drug and may include stomach cramps, aches and pains, coldness, muscle spasms or tension, pounding heart, insomnia, and many others. These symptoms, along with mood changes, like depression and anxiety, are a major reason people with opioid addiction may relapse. Yet until now, no medication has been approved to treat withdrawal.

This week, the Food and Drug Administration (FDA) approved lofexidine, the first medication targeted specifically to treat the physical symptoms associated with opioid withdrawal. NIDA’s medications development program helped fund the science leading to the drug’s approval. Lofexidine could benefit the thousands of Americans seeking medical help for their opioid addiction, by helping them stick to their detoxification or treatment regimens.

Two of the three FDA-approved medications to treat opioid use disorder, methadone and buprenorphine, can be initiated while a person is experiencing withdrawal symptoms, and can help curb craving. However, these medications are not always easy to access, and at this point are only received by a minority of people with opioid use disorder. The third FDA-approved drug, extended-release naltrexone, has also been found effective, but only after people have been fully detoxified.  The need to detox first—and endure those symptoms—prevents many patients from being treated with naltrexone. Lofexidine could make a big difference in making the latter treatment option more widely used.

New Nonopioid Med Blunts Drug Withdrawal Symptoms  < Medscape

Lofexidine is not an opioid. It acts to inhibit the release of norepinephrine in the brain and elsewhere in the nervous system. It was originally developed as a medication for hypertension, but has mainly been used for opioid withdrawal in the United Kingdom since the early 1990s. US WorldMeds acquired a license for lofexidine from Britannia Pharmaceuticals in 2003 and will market it in the US under the brand name LUCEMYRATM beginning this summer. NIDA helped fund the clinical trials to test lofexidine’s pharmacological properties, safety, and efficacy in patients who were discontinuing opioid use under medical supervision.

Lofexidine cannot address the psychological symptoms of opioid withdrawal; further research is needed to develop medications that could address mood problems during detoxification and after. But approval of the first medication to treat the physical symptoms of opioid withdrawal is a major milestone, one that could improve the lives and treatment success of thousands of people living with opioid addiction. And by helping prevent relapse, it could save lives. The approval of lofexidine is also a welcome example of the power of public-private collaborations in developing new treatments.

MIAMI — Lofexidine (Lucemyra, US Worldmeds), which has been in use in the United Kingdom for more than 20 years, is now
available in the United States. The drug is used in the management of symptoms of severe opioid withdrawal.
Dr Danesh Alam
In a double-blind, placebo-controlled, multicenter trial in opioid-dependent patients, lofexidine significantly improved opioid
withdrawal symptoms and significantly increased completion of a 7-day opioid discontinuation treatment program compared with
“We desperately need something to address the opioid crisis, where we are losing about 100 Americans every day, with some
16 million on opioids,” Danesh Alam, MD, Northwestern Medicine Central Dupage Hospital, Winfield, Illinois, told Medscape
Medical News.
“Now we have a drug that actually enables us to achieve a rapid withdrawal from opioids. When we use lofexidine, we can
literally bring in someone using opioids, give them this drug, and they can immediately stop using opioids,” said Alam.
The study was presented at the American Society for Clinical Psychopharmacology (ASCP) 2018.
A Better Alternative
Currently, the standard of care for the treatment of opioid withdrawl is medication-assisted therapy with buprenorphine (multiple
brands), but many patients wish to stop using opioids completely, Alam said.
“Buprenorphine is essentially another opioid, albeit a designer opioid, but a number of patients object to clinicians saying that
the best evidence is to switch them over to buprenorphine and do buprenorphine for the rest of their life,” he said.
Lofexidine, a selective alpha-2-adrenergic agonist, acts on the central nervous system. Through its effect on the brain stem, it
reduces the symptoms of withdrawal to a point at which they become very tolerable.
“We found in our study that you could basically give patients the lofexidine and stop the opiate. In the majority of cases, the
withdrawal symptoms at that point were mild,” Alam said.
The researchers enrolled 602 men and women aged 18 years or older who sought treatment for dependence on short-acting
opioids. Most were men (71%); the mean age of the patients was 35 years (±11 years).
Most patients (83%) were dependent on heroin.
Participants were randomly assigned to receive placebo, lofexidine 0.6 mg qid (2.4 mg/day), or lofexidine 0.8 mg qid (3.2
mg/day) for 7 days after abrupt opioid discontinuation.
The study assessed the benefit of lofexidine with the Short Opiate Withdrawal Scale–Gossop (SOWS-G), a 10-item inventory of
common opioid withdrawal symptoms in which higher scores indicate worse symptoms; by the percentage of participants who
completed the study; and by use of the Clinical Opiate Withdrawal Scale (COWS), an 11-item inventory of opioid withdrawal
signs and symptoms in which higher scores indicate worse symptoms.

Scores on the SOWS-G were lower for patients treated with lofexidine at both doses compared to patients given placebo (-0.21
for lofexidine 2.4 mg, P = .02; and -0.26 for lofexidine 3.2 mg, P = .003). More patients in the lofexidine-treated group completed
the 7-day trial than in the placebo group (41.5% in the 2.4-mg group (odds ratio [OR], 1.85, P = .007), and 39.6% in the 3.2-mg
group (OR, 1.71; P = .02), vs 27.8% for placebo.
Mean COWS scores were significantly lower on days 1 to 5 for patients in the lofexidine groups than for patients who received
placebo (P < .01).
Good Timing
The most common side effects seen with lofexidine were hypotension, orthostatic hypotension, and bradycardia, but they
resulted in few study discontinuations.
The US debut of lofexidine comes at a crucial time. It was recently granted approval by the US Food and Drug Administration
(FDA), as reported by Medscape Medical News.
This approval came after 17 years of hard work on the part of the National Institute on Drug Abuse (NIDA).