Probuphine Notice October 2020

Dear Healthcare Professional Letter 

Titan Announces Voluntary Withdrawal and Discontinuation of Commercial Availability of PROBUPHINE® (buprenorphine) implant CIII for the maintenance treatment of opioid dependence in eligible patients 

IMPORTANT PRESCRIBING INFORMATION

October 19, 2020

Dear Healthcare Professional,

Due to a number of factors that have negatively impacted the uptake and utilization of Probuphine, Titan is voluntarily withdrawing and discontinuing commercial availability of Probuphine in the United States commencing October 15, 2020.  It is important to note that this difficult but necessary decision was unrelated to any safety concerns.

Probuphine is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine- containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet or generic equivalent).

Factors leading to the discontinuation include the onerous requirements of the current product label, the Risk Evaluation and Mitigation Strategy (REMS) program, and the complexity of the distribution system, which all significantly impeded our ability to commercialize Probuphine.  Other considerations included the financial constraints that have limited our sales and marketing capabilities, and suboptimal reimbursement rates.  The COVID-19 pandemic has further exacerbated these issues and, taken together, these factors have necessitated the withdrawal of the product.  Titan is not permitting any new treatments with Probuphine, however, we will continue to provide REMS-related support to healthcare providers with patients in active treatment.

We wish to express our gratitude to you for the important work you do in treating patients with opioid use disorder and appreciate that this may be difficult news to share with patients who may be in treatment with Probuphine or who had been considering it.

If you require more information about Probuphine, please contact Titan at 1-844-859-6341.  We encourage you to report negative side effects to Titan at 1-844-859-6341 or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Below we have provided answers to anticipated questions you may have during this process. Also, please refer to the full Probuphine Prescribing Information for complete safety and other product information (https://TitanPharm.com/Probuphine-PI).

We hope you find this information helpful in understanding this subject so you can continue to appropriately treat your patients.

With sincere regards,

Kate Beebe DeVarney, Ph.D.
President and Chief Operating Officer
Titan Pharmaceuticals, Inc.


TTN-PRO-262-1-OCT20




FREQUENTLY ASKED QUESTIONS

1. Why was Probuphine discontinued? Was it due to safety issues?

  • The onerous requirements of the current product label, the Risk Evaluation and Mitigation Strategy, or REMS, program and the complexity of the distribution system have significantly impeded our ability to successfully commercialize Probuphine. Other factors leading to this include the Company’s financial constraints that have limited our sales and marketing capabilities along with suboptimal reimbursement rates. In recent months, the general uncertainty and challenges due to the ongoing global COVID-19 pandemic have further exacerbated these issues.
  • Importantly, the difficult decision to voluntarily withdraw and discontinue the commercial availability of Probuphine, effective October 15, 2020, is not related to any safety issues.
  • Titan is currently focused on reducing its operating costs and restructuring the organization in order to best position the Company for future growth opportunities.
  • Despite these difficult steps to help preserve the future of Titan, the Company remains committed to addressing the unmet needs of patients, their caregivers and the practitioners that treat opioid use disorder. 

2. What do I do when my patient has completed their 6-month period of Probuphine treatment?

  • Effective October 15, 2020, Probuphine will no longer be available.
  • At the end of the 6-months of treatment, the Probuphine implant must be removed and your patient should be maintained on their previous dosage of transmucosal buprenorphine (i.e., the dose from which they were transferred to PROBUPHINE treatment). 
  • Titan will be sending to you a Probuphine removal kit if you have received a Probuphine implant kit within the last 10 months since January 2020.
  • Please confirm removal of your patients implants by contacting Titan at 1-844-859-6341.

3. I recently placed a Probuphine implant in my patient, may I continue treatment?

  • You may continue your patient’s treatment with Probuphine implant and remove it at the end of the 6 months of treatment.
  • Titan will be sending to you a Probuphine removal kit if you have received a Probuphine implant kit within the last 10 months since January 2020.

4. What happens if an implant protrudes or expulses, will I be able to obtain a replacement implant?

  • Effective October 15, 2020, Probuphine will no longer be available. If you happen to have a patient who experiences an implant protrusion or expulsion, please report this as an adverse event by contacting Titan at 1-844-859-6341 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.
  • If an implant protrudes or expulses during the course of treatment you should remove the remaining implants and maintain the patient on their previous dosage of transmucosal buprenorphine (i.e., the dose from which they were transferred to Probuphine treatment).

5. What if I have medical or scientific questions regarding Probuphine?

  • Please contact Titan at 1-844-859-6341 for further inquiries

6. What if I need to review the removal procedure?

7. What if I plan to remove one implant at a time, to taper my patient off Probuphine; will I have access to removal kits?

  • The effects of tapering or leaving implant(s) in place at the end of 6 months have not been prospectively studied and is considered off-label use.
  • Titan will be sending to you a Probuphine removal kit if you have received a Probuphine implant kit within the last 10 months since January 2020.

8. I have a patient scheduled in the next 2 weeks for implant, may I proceed with the procedure?

  • Effective October 15, 2020, Probuphine will no longer be available.
  • Titan is not permitting any new treatments with Probuphine beyond October 16, 2020.

9. Where do I get a Probuphine removal kit?

  • Titan will be sending to you a Probuphine removal kit if you have received a Probuphine implant kit within the last 10 months since January 2020.

10. Where do I report adverse events?

  • To report suspected adverse reactions, contact Titan at 1-844- 859-6341 or FDA at 1-800-FDA-1088 or fda.gov/medwatch

11. What if I don’t send back kits and I decide to use on a patient in the future?

  • Titan is not permitting any new treatments with Probuphine beyond October 16, 2020.

12. How do I return my unused Probuphine implant kits and will I be reimbursed?

  • The returned kits should be returned through the same channel through which they were purchased. 
    • If the kits were purchased through (supplied by) a specialty pharmacy, then they should be returned to the specialty pharmacy.
    • If the kits were purchased (supplied) directly from McKesson (buy and bill), then they should be returned to McKesson.
  • Reimbursement should be provided by the respective supplier in accordance with the terms of the original purchase.
  • Please contact Titan at 1-844-859-6341 for specific instructions on how to return these materials.
  • Once the return process is completed, you will receive reimbursement for your kit.

13. How do I find out more details regarding Titan’s decision to voluntarily withdraw Probuphine from commercial availability?

14. For any additional inquiries, please contact Titan at 1-844-859-6341.

15. For Probuphine’s Full Prescribing Information, please refer to: https://TitanPharm.com/Probuphine-PI


TTN-PRO-263-1-OCT20