SOUTH SAN FRANCISCO, Calif., June 16, 2020 /PRNewswire/ — Titan Pharmaceuticals, Inc.. (NASDAQ: TTNP) (“Titan” or the “Company”) at present introduced that it has initiated a fully-virtual Probuphine® (buprenorphine) implant Risk Evaluation and Mitigation Strategy (“REMS”) coaching and certification program for certified well being care suppliers (“HCPs”) who deal with sufferers with Opioid Use Disorder (“OUD”).
The U.S. Food and Drug Administration (“FDA”) has accepted the digital REMS coaching program to be used in the course of the COVID-19 pandemic to assist the protection of HCPs, their employees and the coaching personnel. The program is now accessible to certified HCPs at remedy facilities throughout the U.S.
“We are grateful for the FDA’s expeditious review and approval of our fully-virtual REMS training program, which enables us to continue to certify HCPs to prescribe and administer Probuphine during this critical time when rates of opioid-related morbidity and mortality are significantly increasing,” mentioned Titan’s Executive Vice President and Chief Scientific Officer, Dr. Kate Beebe DeVarney. “We believe that the ability to continue certifying HCPs amidst the pandemic will facilitate access to our six-month maintenance treatment option for eligible patients with OUD who are now at increased risk for infection, relapse, and overdose due to the COVID-19 health crisis.”
Please see Probuphine Full Indication and Important Safety Information and Boxed Warning under, and hyperlink under to Full Prescribing Information.
“A few days ago, I had the honor of becoming Titan’s first HCP to receive fully-virtual training on prescribing, inserting, and removing Probuphine,” mentioned Dr. Christopher Ray, of Phoenix, Arizona. “Titan’s virtual, REMS training is so well-planned, organized and thorough in every detail that I feel comfortable prescribing Probuphine treatment to eligible OUD patients receiving buprenorphine maintenance therapy, particularly given the COVID-19 pandemic-related restrictions that limit the frequency of face-to-face interaction with patients. I would recommend this virtual Probuphine REMS training to any qualified HCP providing long-term buprenorphine maintenance treatment for OUD.”
Probuphine is the one subdermal implant designed to ship buprenorphine repeatedly for six months following insertion.
Probuphine was developed utilizing ProNeura®, the continual drug supply system developed by Titan that consists of a small, stable implant constructed from a combination of ethylene-vinyl acetate and a drug substance. The ensuing assemble is a stable matrix that’s positioned subdermally, usually within the higher internal arm in an outpatient workplace process and eliminated in an identical method on the finish of the remedy interval. The U.S. Food and Drug Administration (“FDA”) accepted Probuphine in May 2016, and it’s the first and solely buprenorphine implant accessible for the upkeep remedy of opioid dependancy in eligible sufferers.
IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING
PROBUPHINE is an implant that accommodates the drugs buprenorphine. PROBUPHINE is used to deal with sure adults who’re hooked on (depending on) opioid medicine (both prescription or unlawful). PROBUPHINE is indicated for the upkeep remedy of opioid dependence in sufferers who’ve achieved and sustained extended medical stability on low-to-moderate doses (doses not more than eight mg per day) of a buprenorphine-containing product.
PROBUPHINE is a part of a whole remedy program that additionally contains counseling and behavioral remedy.
It just isn’t recognized if PROBUPHINE is secure or efficient in kids lower than 16 years of age.
WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE
Serious problems might occur from insertion and removing of PROBUPHINE, together with:
Call your healthcare supplier immediately if:
- PROBUPHINE stands proud of the pores and skin or comes out by itself
- You have bleeding or signs of an infection on the website after insertion or removing, together with extreme or worsening itching, ache, irritation, redness, or swelling
- You have numbness or weak spot in your arm after the insertion or removing process
- You have weak spot or numbness in your arm, or shortness of breath
If the implant comes out by itself, hold it away from others, particularly kids, as it could trigger extreme problem in respiration and probably demise.
Because of the danger of problems of, migration, protrusion, expulsion and nerve harm with insertion and removing of PROBUPHINE, it’s only accessible by way of a restricted program referred to as the PROBUPHINE REMS Program. Healthcare suppliers who prescribe and/or insert PROBUPHINE should be licensed with this system by enrolling and finishing stay coaching.
- PROBUPHINE just isn’t accessible in retail pharmacies
- PROBUPHINE should be inserted or eliminated solely within the facility of the licensed prescriber
Implants could also be troublesome to find if inserted too deeply, should you manipulate them, or should you acquire important weight after insertion. Your healthcare supplier might do particular procedures or assessments, or refer you to a surgical specialist to take away the implants if they’re troublesome to find.
The drugs in PROBUPHINE may cause critical and life-threatening issues, particularly should you take or use sure different medicines or medicine. Call your healthcare supplier immediately or get emergency assist should you:
Feel faint or dizzy, have psychological modifications akin to confusion, slower respiration than you usually have, extreme sleepiness, blurred imaginative and prescient, issues with coordination, slurred speech, can’t suppose effectively or clearly, excessive physique temperature, slowed reflexes, really feel agitated, stiff muscle tissues or have bother strolling.
These will be indicators of an overdose or different critical issues.
Coma or demise can occur should you take nervousness medicines or benzodiazepines, sleeping tablets, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol throughout remedy with PROBUPHINE. Tell your healthcare supplier in case you are taking any of those medicines or should you drink alcohol.
Who shouldn’t use PROBUPHINE?
Do not use PROBUPHINE in case you are allergic to buprenorphine or any of its elements, this contains buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.
PROBUPHINE might not be best for you. Before beginning PROBUPHINE inform your physician about your whole medical situations, together with:
Trouble respiration or lung issues, an enlarged prostate gland (males), a head harm or mind drawback, issues urinating, a curve in your backbone that impacts your respiration, liver issues, gallbladder or adrenal gland issues, Addison’s illness, low thyroid hormone ranges (hypothyroidism), a historical past of alcoholism, a historical past of keloid formation, connective tissue illness (akin to scleroderma), or historical past of MRSA infections, psychological issues akin to hallucinations, an allergy to numbing medicines or medicines used to wash your pores and skin, are pregnant or plan to grow to be pregnant or are breastfeeding or plan to breastfeed.
Tell your physician about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins and natural dietary supplements.
What ought to I keep away from whereas being handled with PROBUPHINE?
- Do not drive, function heavy equipment, or carry out some other harmful actions till you know the way this treatment impacts you
- You shouldn’t drink alcohol throughout remedy. You shouldn’t take nervousness medicines or benzodiazepines, sleeping tablets, tranquilizers, or sedatives that aren’t prescribed to you throughout remedy with PROBUPHINE, as this could result in slowed respiration, drowsiness, delayed response time, lack of consciousness and even demise
What are the doable negative effects of PROBUPHINE?
PROBUPHINE may cause critical negative effects, together with:
- Infection on the insertion or removing website. Infection might occur on the implant website throughout insertion or removing. Do not attempt to take away PROBUPHINE implants your self
- Opioid withdrawal. If PROBUPHINE comes out of your arm or should you cease remedy, inform your physician immediately as you may have signs of shaking, sweating greater than regular, feeling scorching or chilly greater than regular, runny nostril, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
- Physical dependency
- Liver issues. Call your physician immediately should you discover indicators of liver issues that will embrace your pores and skin or the white a part of your eyes turning yellow (jaundice)
- Allergic response. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood strain, dizziness or lower in consciousness
- Decrease in blood strain. You might really feel dizzy whenever you rise up from sitting or mendacity down
- Sleep Apnea. Call your physician immediately should you or somebody near you notices: Observed episodes of stopped respiration or irregular respiration patterns throughout sleep
Tell your healthcare supplier should you develop any of the signs listed.
Common negative effects of PROBUPHINE embrace: Headache, nausea, toothache, constipation, despair, vomiting, again ache, mouth and throat ache.
Common dangers with the minor surgical process: Itching, ache, irritation, redness, swelling, bleeding, or bruising on the insertion or removing website. Scarring across the insertion website.
Please learn Full Prescribing Information, together with BOXED WARNING concerning IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.
Titan encourages you to report unfavourable negative effects of pharmaceuticals to the FDA. You can go to www.fda.gov/security/medwatch/ or name 1-800-FDA-1088.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based mostly in South San Francisco, CA, is a industrial stage firm creating proprietary therapeutics with its ProNeura® long-term, steady drug supply expertise. The Company’s lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term upkeep remedy of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the primary and solely commercialized remedy of opioid dependence to supply steady, around-the-clock blood ranges of buprenorphine for six months following a single process. The ProNeura expertise additionally has the potential for use in creating merchandise for treating different power situations akin to Parkinson’s illness and hypothyroidism, the place sustaining constant, around-the-clock blood ranges of treatment might profit the affected person and enhance medical outcomes. For extra details about Titan, please go to www.titanpharm.com.
This press launch might include “forward-looking statements” throughout the which means of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements embrace, however will not be restricted to, any statements referring to our product growth packages and some other statements that aren’t historic information. Such statements contain dangers and uncertainties that would negatively have an effect on our enterprise, working outcomes, monetary situation and inventory worth. Factors that would trigger precise outcomes to vary materially from administration’s present expectations embrace these dangers and uncertainties referring to the commercialization of Probuphine; the regulatory approval course of; Titan’s skill to entry capital; the event, testing, manufacturing and advertising and marketing of our drug candidates; patent and mental property issues; and strategic agreements and relationships. We expressly disclaim any obligation or endeavor to launch publicly any updates or revisions to any forward-looking statements contained herein to replicate any change in our expectations or any modifications in occasions, situations or circumstances on which any such assertion relies, besides as required by regulation.
President & CEO
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SOURCE Titan Pharmaceuticals, Inc.