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Titan Pharmaceuticals, Inc.
 
                                                                                                                           Click For New and Improved Website

                                                                                                                                   Probuphine Logo
                                                                                                                                                                    

                  5/26/2016-FDA Approves First Buprenorphine Implant For Treatment Of Opioid Dependence
 
                                             Expanded use and availability of medication-assisted treatment is a top priority of federal effort to combat opioid epidemic

                                                                       
                                                                   
                                                              Probuphine Healthcare Provider Locator



 

 

The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

Until today, buprenorphine for the treatment of opioid dependence was only approved as a pill or a film placed under the tongue or on the inside of a person’s cheek until it dissolved. While effective, a pill or film may be lost, forgotten or stolen. However, as an implant, Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis. An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year.

"Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA Commissioner Robert M. Califf, M.D. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Expanding the use and availability of medication-assisted treatment (MAT) options like buprenorphine is an important component of the FDA’s opioid action plan and one of three top priorities for the U.S. Department of Health and Human Services’ Opioid Initiative aimed at reducing prescription opioid and heroin related overdose, death and dependence.

Opioid dependence is the diagnostic term used for the more common concept, “addiction,” in the Probuphine clinical trials. Addiction is defined as a cluster of behavioral, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use, persisting in drug use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, as well as the possibility of the development of tolerance or development of physical dependence. Physical dependence is not the same as addiction. Newer diagnostic terminology uses the term “opioid use disorder,” which includes both milder forms of problematic opioid use as well as addiction.

MAT is a comprehensive approach that combines approved medications (currently, methadone, buprenorphine or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder. Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use, without causing the cycle of highs and lows associated with opioid misuse or abuse. At sufficient doses, it also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for their opioid use disorder cut their risk of death from all causes in half.

“Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence,” said Nora Volkow, M.D., director of the National Institute on Drug Abuse at the National Institutes of Health. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”

Probuphine should be used as part of a complete treatment program that includes counseling and psychosocial support. Probuphine consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm and provide treatment for six months. Administering Probuphine requires specific training because it must be surgically inserted and removed. Only a health care provider who has completed the training and become certified through a restricted program called the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program should insert and remove the implants. If further treatment is needed, new implants may be inserted in the opposite arm for one additional course of treatment. The FDA is requiring postmarketing studies to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment.

The safety and efficacy of Probuphine were demonstrated in a randomized clinical trial of adults who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment. A response to MAT was measured by urine screening and self-reporting of illicit opioid use during the six month treatment period. Sixty-three percent of Probuphine-treated patients had no evidence of illicit opioid use throughout the six months of treatment – similar to the 64 percent of those who responded to sublingual (under the tongue) buprenorphine alone.

The most common side effects from treatment with Probuphine include implant-site pain, itching, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain. The safety and efficacy of Probuphine have not been established in children or adolescents less than 16 years of age. Clinical studies of Probuphine did not include participants over the age of 65.

Probuphine has a boxed warning that provides important safety information for health care professionals, including a warning that insertion and removal of Probuphine are associated with the risk of implant migration, protrusion, expulsion and nerve damage resulting from the procedure. Probuphine must be prescribed and dispensed according to the Probuphine REMS program because of the risks of surgical complications and because of the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin. As part of this program, Probuphine can only be prescribed and dispensed by health care providers who are certified with the REMS program and have completed live training, among other requirements.

Probuphine implants contain a significant amount of drug that can potentially be expelled or removed, resulting in the potential for accidental exposure or intentional misuse and abuse if the implant comes out of the skin. Patients should be seen during the first week after insertion and a visit schedule of no less than once-monthly is recommended for continued counseling and psychosocial support.

Probuphine is marketed by San Francisco-based Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals based in Princeton, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

 

CLINICAL SUMMARY

SIX CLINICAL STUDIES COMPLETED TO DATE WITH FINAL PHASE 2 STUDY UNDER WAY
1 Initial small dose finding study
2 & 3 Two well-controlled Phase 3 safety and efficacy studies showing clinical and statistical superiority over placebo and non-inferiority to Suboxone published in Journal of American Medical Association and Addiction
4 & 5 Two open-label long-term treatment safety studies
6 Relative bioavailability study



 
STUDY RESULTS
  • Mild-to-moderate adverse events typical of the safety profile of buprenorphine; low number of serious adverse events similar to placebo
    Well-tolerated implant procedure
    No evidence of implant diversion or misuse

KEY BENEFITS

EFFICACY

Effective in reducing illicit opioid use

COMPLIANCE

Treatment with the ProNeura™ implant is expected to enhance patient compliance

SAFETY

Non-fluctuating drug exposure over six months may provide superior safety and tolerability

EASE OF USE

Patients are dosed once every six months in an outpatient setting

 

PRONEURA™

Titan's proprietary long-term, drug delivery platform provides continuous drug release and non-fluctuating medication levels over a period of three months to a year depending on drug characteristics. ProNeura products are subdermal implants that are ideal for treating chronic diseases for which the maintenance of stable medication levels could offer advantages over other routes of administration.

   OVERVIEW

    ProNeura offers continuous drug delivery and consists of a small, solid rod made from a mixture of ethylene-vinyl acetate (“EVA”) and a drug substance.                                                     .   The resulting product is a solid matrix that is placed subcutaneously, normally in the inner part of the upper arm in a simple office procedure, and is 
    removed in a similar manner at the end of the treatment period.

   
    This continuous drug delivery technology was developed to address the need for a simple, practical method to potentially provide continuous drug administration on an 
    outpatient basis over extended periods of up to 6 to 12 months.

Overview

 

 

 

 

Continuous Drug Delivery Technology

 

 

The continuous drug delivery system consists of a small, solid rod made from a mixture of ethylene-vinyl acetate (“EVA”) and a drug substance. The resulting product is a solid matrix that is placed subcutaneously, normally in the inner part of the upper arm in a simple office procedure, and is removed in a similar manner at the end of the treatment period. The drug substance is released slowly, at continuous levels, through the process of dissolution. This results in a stable blood level similar to intravenous administration. Such long-term, linear release characteristics are generally desirable as this avoids peak and trough level dosing that poses problems for many Central Nervous System (“CNS”) and other disease settings. 

This continuous drug delivery technology was developed to address the need for a simple, practical method to potentially provide continuous drug administration on an outpatient basis over extended periods of up to 6-12 months. In addition to Probuphine, which is the first product to complete clinical testing that has utilized this proprietary continuous drug delivery technology, Titan has conducted initial non-clinical studies with long-term delivery of dopamine agonists demonstrating the potential of this product in the treatment of Parkinson’s disease in non-clinical models of the disease.

 


 


Company Overview



 

Titan Pharmaceuticals, Inc. is a biopharmaceutical Company developing proprietary therapeutics primarily for the treatment of serious medical disorders.


Titan’s principal asset is Probuphine®, the first slow-release implant formulation of buprenorphine hydrochloride (“buprenorphine”), designed to maintain a stable, round-the-clock blood level of the medicine in patients for up to six months following a single treatment. The outpatient treatment of opioid dependence with daily dosed sublingual buprenorphine formulations represents a $1.5 billion market in the U.S., and a seven day transdermal patch formulation of buprenorphine for the treatment of chronic pain was launched in the U.S. in 2011. This novel implant formulation is inserted subdermally in a patient’s upper arm providing continuous medication, and has the potential to enhance patient compliance to treatment, and limit diversion for illicit use and accidental exposure to the sublingual formulations. An FDA-requested Phase 3 study is currently in progress with completion expected in mid-2015 and resubmission of the New Drug Application later in 2015. In December 2012, Titan entered into a license agreement with Braeburn Pharmaceuticals Sprl (“Braeburn”) that grants Braeburn exclusive commercialization rights to Probuphine® in the United States and Canada. Titan received a non-refundable up-front license fee of $15.75 million and will receive a $15 million milestone payment upon the approval of the NDA by the FDA. Additionally, Titan will be eligible to receive up to $165 million upon achievement of specified sales milestones and up to $35 million in regulatory milestones in the event of future NDA submissions and approvals for additional indications, including chronic pain. Titan will receive tiered royalties on net sales of Probuphine ranging from the mid-teens to the low twenties.


Probuphine is the first product to utilize ProNeura™, a novel, proprietary, long-term drug delivery technology. The ProNeura technology has the potential to be used in developing products for the treatment of other chronic conditions, such as Parkinson’s disease, where maintaining stable, round-the-clock blood levels of a drug can benefit the patient and improve medical outcomes.


Finally, Titan has monetized substantially all of the future royalty revenue of 8-10% of net sales of Fanapt® (iloperidone), an atypical antipsychotic compound being marketed in the U.S. for the treatment of schizophrenia by Novartis Pharma AG (“Novartis”). The future royalty revenue has been sold to Deerfield Management (“Deerfield”), a healthcare investment fund, in exchange for cash and debt considerations which have been used to advance the development of Probuphine and for general corporate purposes.

 

 

Management Team

President
Sunil Bhonsle, M.B.A.

Executive Vice President and Chief Development Officer

Katherine L. Beebe, Ph.D.

Executive Chairman

Marc Rubin, M.D.

 



Board of Directors

 
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#11141   Road Show Takeaways.... Doctor Detroit 01/19/17 07:16:54 PM
#11140   Braeburn Road Show Presentation Doctor Detroit 01/19/17 06:34:33 PM
#11139   Yes it would be,I read somewhere maybe one turks 01/18/17 07:03:49 PM
#11138   Along with chronic pain.... Doctor Detroit 01/18/17 06:42:52 PM
#11137   Turks, Yep...Apple Tree appears to be buying $90 million Doctor Detroit 01/18/17 12:56:02 PM
#11136   First trade date expected 2/2 Doctor Detroit 01/18/17 12:50:42 PM
#11135   Opioid addiction biotech Braeburn Pharmaceuticals sets terms for Doctor Detroit 01/18/17 12:49:38 PM
#11134   Doc,thank uou.think we'really going to be in real turks 01/18/17 11:39:22 AM
#11133   Turks..yes check out page 10 of amended S-1 Doctor Detroit 01/18/17 11:25:28 AM
#11132   EXACTLY!!THAT'S why I believe titan is the better turks 01/18/17 10:53:02 AM
#11131   An approved drug is potentially good for both companies. shadolane 01/18/17 10:47:03 AM
#11130   For what it's worth... Doctor Detroit 01/18/17 10:29:25 AM
#11129   Hat's Off... Doctor Detroit 01/18/17 10:09:55 AM
#11128   Braeburn post-IPO market Cap Doctor Detroit 01/18/17 10:08:16 AM
#11127   Amended S-1 reflecting the pricing Doctor Detroit 01/18/17 10:01:42 AM
#11126   Braeburn offering has priced Doctor Detroit 01/18/17 10:00:18 AM
#11125   Nice of you to be so hopefully pessimistic---Hopefully, rikshot 01/17/17 01:55:39 PM
#11124   No. It isn't amazing. At all. Markets trade matthewverymuch 01/17/17 09:49:14 AM
#11123   Oh!!!the market will definitely figure it out,sales will turks 01/16/17 07:29:23 PM
#11122   ------------------- "...so they will spending more on probuphine then F1ash 01/16/17 04:17:03 PM
#11121   It's interesting that breaburn IPO will raise about turks 01/16/17 09:11:25 AM
#11120   Anti-Cocaine Vaccine Approved for Clinical Study in Humans TRUTH 01/16/17 08:04:03 AM
#11119   SO,HAs THE QUITE PERIOD ENDED?is the roadshow for turks 01/14/17 03:14:22 PM
#11118   What's everyone's take on the Braeburn iPo news? Gman2488 01/13/17 01:00:00 PM
#11117   Pain trial press release won't come until Braeburn's Doctor Detroit 01/13/17 11:42:22 AM
#11116   I think I read somewhere that they where turks 01/13/17 11:18:06 AM
#11115   The procedure is reimbursed, but it doesn't have Doctor Detroit 01/13/17 10:35:08 AM
#11114   It's a weird press release, that's for sure. Doctor Detroit 01/13/17 10:33:18 AM
#11113   Interesting thing about this,is that as truth also turks 01/13/17 10:28:22 AM
#11112   We are forward at least, I would be stocky101 01/13/17 10:03:18 AM
#11111   The procedure isn't reimbursed? Is that right? Dot matthewverymuch 01/13/17 09:53:29 AM
#11110   We should be north of $8 right now stocky101 01/13/17 09:46:19 AM
#11109   Titan may be asleep at the wheel, but gimmeshelter 01/13/17 09:38:17 AM
#11108   $6 Coming stocky101 01/13/17 09:32:20 AM
#11107   *RE-POST FROM JANUARY 2, 2017 Pertaining To J Code* TRUTH 01/13/17 08:44:35 AM
#11106   Ironically it was a GOP congress with GWBush gimmeshelter 01/12/17 01:26:58 PM
#11105   I hope this isn't spooking the IPO market Doctor Detroit 01/12/17 12:46:38 PM
#11104   Not that it matters,there was a gap at turks 01/12/17 09:52:20 AM
#11103   Shorts keep going lower: EMA1 01/12/17 04:42:56 AM
#11101   Thanks for confirmation, nice to know not losing Rentier 01/11/17 06:23:32 PM
#11100   The info that Dr Detroit posted on post rikshot 01/11/17 01:30:52 PM
#11099   What info? matthewverymuch 01/11/17 01:12:54 PM
#11096   Next week starts breaburn's roadshow,it will be over turks 01/11/17 12:37:58 PM
#11095   Yeah, the Canadian license happened about a year Doctor Detroit 01/11/17 09:24:56 AM
#11094   I searched Knight Pharma (GUD) with probuphine added---only rikshot 01/10/17 09:13:39 PM
#11093   I think someone talked about that last year Rentier 01/10/17 07:40:11 PM
#11092   I haven't seen much either other than a Doctor Detroit 01/10/17 06:51:57 PM
#11091   Only interesting new thing I have seen on Rentier 01/10/17 06:28:07 PM
#11090   I meant to say waiting fran12345 01/09/17 05:49:39 PM
#11089   I've been waiting three years I'm gonna keep fran12345 01/09/17 05:24:55 PM
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