LUND, Sweden, Nov.
28, 2018 /PRNewswire/ -- Camurus announced today that the
Australian Therapeutic Goods Administration (TGA) has approved the
company's lead products Buvidal® Weekly and Buvidal® Monthly
(CAM2038) for maintenance treatment of opioid dependence within a
framework of medical, social and psychosocial support.
"Opioid dependence and non-mePhoto -
http://www.camurus.com/dical opioid use are large and growing
issues in Australia with
significant negative impact on individuals, their families and the
wider community," said Fredrik
Tiberg, President and CEO of Camurus. "Today's approval of
Buvidal Weekly and Buvidal Monthly will for the first time give
Australian patients access to a long-acting buprenorphine treatment
for opioid dependence with a meaningful clinical benefit recognized
by the TGA.
Formulated with Camurus' proprietary FluidCrystal® injection
depot technology, Buvidal is a lipid-based solution which, once
injected, transforms into a nanostructured gel-like depot. The
depot slowly biodegrades over time, releasing buprenorphine which
blocks the drug-liking effect of opioids in the brain and reduces
withdrawal, craving and patient's use of illicit
opioids.1-4
"The introduction of Buvidal represents the most significant
development in over 15 years of opioid dependence treatment in
Australia. The flexibility of
weekly and monthly injection depots will make treatment much more
convenient for patients, reducing the costs and inconvenience of
daily dosing, and should serve to lessen the stigma experienced by
many patients," said Professor Nicholas
Lintzeris, Director of Drug & Alcohol Services, South
East Sydney Local Health District and the Division of Addiction
Medicine, Central Clinical School, University
of Sydney.5
The TGA approval of Buvidal Weekly and Buvidal Monthly is based
on safety and efficacy data from a global development program
comprising seven clinical studies, including a randomized,
double-blind, double-dummy, active controlled Phase 3 study in 428
patients with opioid dependence. Results from this study
demonstrated improved treatment outcomes with Buvidal compared to
daily standard treatment with sublingual
buprenorphine/naloxone.4
The Australian approval follows the recent European Commission
approval of Buvidal®, announced 22 November
2018. In the US, the Food and Drug Administration has issued
a PDUFA goal date of 26 December 2018
for CAM2038 to Camurus' US partner Braeburn.
About opioid dependence
Opioid dependence is
an escalating global health problem, contributing to significant
mental, physical and social adverse consequences that include
transmission of infectious diseases, criminal activity and
incarceration, and unintentional overdose and
death.6
Opioid use is a serious public health issue in Australia with an estimated 460,000 people
aged over 14 years having used opioids – including morphine,
oxycodone, methadone and heroin – for non-medical purposes at some
time.7 Of these, 230,000 had used heroin.7 In
2016, 1,808 drug-induced deaths were registered in Australia, the highest number of drug deaths
in 20 years.8 On a sample day in 2017,
approximately 50,000 people in Australia received pharmacotherapy treatment
for opioid dependence.9
About Buvidal Weekly and Buvidal Monthly (CAM2038)
Buvidal Weekly and Buvidal Monthly (modified release solution
for subcutaneous injection) has been developed for the treatment of
opioid dependence within a framework of medical, social and
psychological treatment. Buvidal is designed for flexible weekly
and monthly dosing, allowing tailored treatment to the patient's
individual needs. Each injection should be administered by a health
care professional.
The TGA approval of Buvidal Weekly and Buvidal Monthly is
based on a clinical program with seven clinical studies, including
a randomized, double-blind, double-dummy, active controlled Phase 3
study in 428 patients with opioid dependence. In this pivotal
study, Buvidal was shown to be at least as effective as effective
as standard treatment with daily buprenorphine/naloxone for the
primary endpoint of the mean percent urines negative for illicit
opioids (35.1% versus 28.4%, p<0.001). Superiority was met for
the key secondary endpoint of cumulative distribution function
(CDF) for the percent urine tests negative for illicit opioid use
(p=0.008). The median CDF was 26.7% for Buvidal and 6.7% for
sublingual buprenorphine/naloxone.[4] The safety profile of Buvidal
was comparable to sublingual buprenorphine/naloxone, except for
mild to moderate injection site reactions.
Formulated with Camurus' FluidCrystal injection depot
technology, Buvidal is presented ready for use in pre-filled
syringes for administration as small dose volume subcutaneous
injection through a thin, 23-gauge needle. Buvidal has been
developed for room temperature storage.
About Camurus
Camurus is a Swedish research-based pharmaceutical company
committed to developing and commercialising innovative and
differentiated medicines for the treatment of severe and chronic
conditions. New drug products with best-in-class potential are
conceived based on the company's proprietary FluidCrystal drug
delivery technologies and its extensive R&D expertise. Camurus'
clinical pipeline includes products for the treatment of cancer,
endocrine diseases, pain and addiction, which are developed
in-house and in collaboration with international pharmaceutical
companies. The company's shares are listed on Nasdaq Stockholm
under the ticker CAMX. For more information, visit
www.camurus.com.
PBS information: Buvidal is not listed on the
PBS.
Important safety
information
RISK OF SERIOUS HARM OR
DEATH WITH INTRAVENOUS INJECTION: Serious harm
or death could result if administered intravenously. Buvidal
Weekly and Monthly forms a gel depot upon contact with body fluids
and may cause occlusion, local tissue damage and thrombo-embolic
events, including life threatening pulmonary emboli, if
administered intravenously. CONTRAINDICATIONS: Hypersensitivity to
buprenorphine or to any of the excipients, children less than 16
years of age, severe respiratory insufficiency, severe hepatic
insufficiency (Child-Pugh C), acute alcoholism or delirium tremens,
pregnancy, lactation. SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
General: Opioids may cause orthostatic hypotension in ambulatory
patients. Opioids should be used with caution in patients with:
head injury, intracranial lesions, other circumstances where
cerebrospinal pressure may be increased, or history of seizure,
hypotension, prostatic hypertrophy or urethral stenosis, myxoedema,
hypothyroidism, or adrenal cortical insufficiency (eg Addison's
disease), dysfunction of the biliary tract; the elderly or
debilitated. Opioid-induced miosis, changes in the level of
consciousness or changes in the perception of pain as a symptom of
disease may interfere with patient evaluation or obscure the
diagnosis or clinical course of concomitant disease. Misuse, abuse
and diversion: Buprenorphine is subject to misuse, abuse and
diversion, similar to other opioids, legal or illicit. Buvidal must
be administered directly to the patient by a healthcare
professional. Buvidal should not be made available directly to
patients. Monitor patients carefully for progression of opioid
dependence and drug use. Respiratory depression: Buprenorphine
should be used with care in patients with respiratory insufficiency
(eg chronic obstructive pulmonary disease, asthma, cor pulmonale,
decreased respiratory reserve, hypoxia, hypercapnia, pre-existing
respiratory depression or kyphoscoliosis). The use of buprenorphine
is contraindicated in patients with severe respiratory
insufficiency. Buprenorphine may cause severe, possibly fatal,
respiratory depression in children and non-dependent persons who
accidentally or deliberately ingest it. CNS depression:
Buprenorphine may cause drowsiness particularly when taken together
with alcohol or central nervous system depressants such as
benzodiazepines, tranquillisers, sedatives, gabapentinoids or
hypnotics. Dependence: Buprenorphine is a partial agonist at the µ
(mu)-opioid receptor and chronic administration can produce opioid
dependence. Use in hepatic impairment: Buprenorphine should be used
with caution in patients with moderate hepatic impairment. The use
of buprenorphine is contraindicated in patients with severe hepatic
insufficiency. Use in renal impairment: Caution is recommended when
dosing patients with severe renal impairment (creatinine clearance
< 30 ml/min). INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS
OF INTERACTIONS: Buprenorphine should be used cautiously when
co-administered with: benzodiazepines, gabapentinoids, alcoholic or
medications containing alcohol, other central nervous system
depressants: other opioid derivatives; certain antidepressants,
sedative H1-receptor antagonists, barbiturates, anxiolytics other
than benzodiazepines, neuroleptics, clonidine and related
substances, opioid analgesics, naltrexone and nalmefene, CYP3A4
inhibitors and inducers, monoamine oxidase inhibitors (MAOI).
PREGNANCY AND LACTATION: Use in pregnancy – Pregnancy Category C:
Buvidal is contraindicated in pregnant women Use in lactation:
Buvidal should not be used in breast-feeding women. EFFECTS ON
ABILITY TO DRIVE AND USE MACHINES: Patients should be cautioned
about operating hazardous machinery in case buprenorphine may
affect their ability to engage in such activities. ADVERSE EFFECTS:
The adverse events most frequently reported in the double-blind,
pivotal phase 3 efficacy clinical trial were constipation, symptoms
commonly associated with drug withdrawal, such as headache, nausea,
insomnia and vomiting, injection site related events such as
injection site pain, injection site pruritus and injection site
erythema, urinary tract infection and upper respiratory tract
infection. Adverse reactions reported with buprenorphine: The
following adverse reactions have been reported with the use of
buprenorphine products and may occur with Buvidal. Very common:
Insomnia, headache, nausea, hyperhidrosis, drug withdrawal
syndrome, and pain. Common: Bronchitis, infection, influenza,
pharyngitis, rhinitis, lymphadenopathy, decreased appetite,
agitation, anxiety, depression, hostility, nervousness, paranoia,
thinking abnormal, dizziness, hypertonia, migraine, paraesthesia,
somnolence, syncope, tremor, lacrimal disorder, mydriasis,
palpitations, vasodilatation, cough, dysnpoea, yawning, abdominal
pain, constipation, diarrhoea, dry mouth, dyspepsia,
gastrointestinal disorder, flatulence, vomiting, rash, arthralgia,
back pain, bone pain, muscle spasms, myalgia, neck pain,
dysmenorrhoea, asthenia, chest pain, chills, malaise, oedema
peripheral and pyrexia. OVERDOSE: Respiratory depression, as a
result of central nervous system depression, is the primary symptom
requiring intervention in the case of buprenorphine overdose
because it may lead to respiratory arrest and death. Symptomatic
treatment of respiratory depression, following standard intensive
care measures, should be instituted. Use of an opioid antagonist
(ie naloxone) is recommended, despite the modest effect it may have
in reversing the respiratory symptoms of buprenorphine compared
with its effects on full agonist opioid agents. The long duration
of action of buprenorphine and the modified release from Buvidal,
should be taken into consideration when determining length of
treatment needed to reverse the effects of an overdose. Naloxone
can be cleared more rapidly than buprenorphine, allowing for a
return of previously controlled buprenorphine overdose symptoms.
For information on the management of overdose, contact the Poisons
Information Centre on 131126 (Australia) for advice.
Notes and references
1 Haasen C, Linden M, Tiberg F. Pharmacokinetics
and pharmacodynamics of a buprenorphine subcutaneous depot
formulation (CAM2038) for once-weekly dosing in patients with
opioid use disorder. J Subst Abuse Treat 2017; 78:22–29.
2 Albayaty M, Linden M, Olsson H, Johnsson M,
Strandgården K, Tiberg F. Pharmacokinetic evaluation of once-weekly
and once-monthly buprenorphine subcutaneous injection depots
(CAM2038) versus intravenous and sublingual buprenorphine in
healthy volunteers under naltrexone blockade: an open-label Phase 1
study. Adv Ther 2017;
34(2):560–575.
3 Walsh SL, Comer SD, Lofwall MR, Vince B,
Levy-Cooperman N, Kelsh D, et al. Effect of buprenorphine weekly
depot (CAM2038) and hydromorphone blockade in individuals with
opioid use disorder: a randomized clinical trial. JAMA Psychiatry
2017; 74(9):894–902.
4 Lofwall MR, Walsh SL,
Nunes EV, Bailey GL, Sigmon SC, Kampman KM, et al. Weekly and
monthly subcutaneous buprenorphine depot formulations vs daily
sublingual buprenorphine with naloxone for treatment of opioid use
disorder: A randomized clinical trial. JAMA Intern Med 2018;
178(6)764–773.
5 Dr. Lintzeris is an investigator in the Buvidal
clinical program which was sponsored by Braeburn and Camurus. In
relation to this media announcement, no compensation was provided
to Dr Lintzeris, and the opinions expressed are his own. Dr
Lintzeris has been briefed by Camurus on the approved use of this
product.
6 World Drug Report 2018, United Nations
June 2018
https://www.unodc.org/wdr2018/ Accessed November 2018.
7 National opioid pharmacotherapy statistics
(NOPSAD) 2016.
https://www.aihw.gov.au/reports/alcohol-other-drug-treatment-services/national-opioid-pharmacotherapy-statistics-nopsad-2016/contents/introduction Accessed
November 2018.
8 Australian Bureau of Statistics. Causes of death,
Australia 2016. Drug Induced
Deaths in Australia: A changing
story.
http://www.abs.gov.au/ausstats/abs@.nsf/Lookup/by%20Subject/3303.0~2016~Main%20Features~Drug%20Induced%20Deaths%20in%20Australia~6 Accessed
November 2018.
9 National opioid pharmacotherapy statistics
(NOPSAD)
2017. https://www.aihw.gov.au/reports/alcohol-other-drug-treatment-services/nopsad-2017/contents/summary Accessed
November 2018.
For more information
Fredrik Tiberg, President & CEO
Tel. +46(0)46-286-46-92
ir@camurus.com
Fredrik Joabsson, VP Business Development
Tel. +46(0)70-776-17-37
ir@camurus.com
Ruari MacDonald, Business Unit Head Australia
Tel. +61-418-760-988
ir@camurus.com
This information is information that Camurus AB is obliged to
make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the managing director, at 10.30 pm
CET on 28 November 2018.
This information was brought to you by Cision
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